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Trial Outcomes & Findings for Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus (NCT NCT02093221)

NCT ID: NCT02093221

Last Updated: 2018-09-05

Results Overview

C-peptide concentration during MMTT with high protein energy drink. "Dose" for time frame refers to intake of high protein energy drink.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

Baseline, Week 52 (pre-high protein drink and 15, 30, 60, 90, 120 minutes post-drink)

Results posted on

2018-09-05

Participant Flow

Participant milestones

Participant milestones
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Overall Study
STARTED
15
16
15
15
15
Overall Study
COMPLETED
5
8
6
7
7
Overall Study
NOT COMPLETED
10
8
9
8
8

Reasons for withdrawal

Reasons for withdrawal
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Overall Study
Adverse Event
1
0
0
0
0
Overall Study
Withdrawal by Subject
1
1
4
1
1
Overall Study
Lost to Follow-up
2
0
1
1
0
Overall Study
Death
0
1
0
0
0
Overall Study
Protocol Violation
0
1
0
0
0
Overall Study
Study termination
6
5
4
6
7

Baseline Characteristics

Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
n=15 Participants
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
n=16 Participants
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
n=15 Participants
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Total
n=76 Participants
Total of all reporting groups
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
2 Participants
n=7 Participants
0 Participants
n=31 Participants
9 Participants
n=30 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=99 Participants
15 Participants
n=107 Participants
12 Participants
n=206 Participants
13 Participants
n=7 Participants
15 Participants
n=31 Participants
67 Participants
n=30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
Age, Customized
6 - 11 years
2 Participants
n=99 Participants
3 Participants
n=107 Participants
3 Participants
n=206 Participants
3 Participants
n=7 Participants
2 Participants
n=31 Participants
13 Participants
n=30 Participants
Age, Customized
12 - 17 years
7 Participants
n=99 Participants
7 Participants
n=107 Participants
7 Participants
n=206 Participants
7 Participants
n=7 Participants
6 Participants
n=31 Participants
34 Participants
n=30 Participants
Age, Customized
18 - 35 years
6 Participants
n=99 Participants
6 Participants
n=107 Participants
5 Participants
n=206 Participants
5 Participants
n=7 Participants
7 Participants
n=31 Participants
29 Participants
n=30 Participants
Sex: Female, Male
Female
6 Participants
n=99 Participants
8 Participants
n=107 Participants
9 Participants
n=206 Participants
4 Participants
n=7 Participants
4 Participants
n=31 Participants
31 Participants
n=30 Participants
Sex: Female, Male
Male
9 Participants
n=99 Participants
8 Participants
n=107 Participants
6 Participants
n=206 Participants
11 Participants
n=7 Participants
11 Participants
n=31 Participants
45 Participants
n=30 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
2 Participants
n=7 Participants
0 Participants
n=31 Participants
3 Participants
n=30 Participants
Race (NIH/OMB)
White
14 Participants
n=99 Participants
14 Participants
n=107 Participants
15 Participants
n=206 Participants
13 Participants
n=7 Participants
15 Participants
n=31 Participants
71 Participants
n=30 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
2 Participants
n=30 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants

PRIMARY outcome

Timeframe: Baseline, Week 52 (pre-high protein drink and 15, 30, 60, 90, 120 minutes post-drink)

Population: Twelve subjects prematurely discontinued from the study prior to Week 52.

C-peptide concentration during MMTT with high protein energy drink. "Dose" for time frame refers to intake of high protein energy drink.

Outcome measures

Outcome measures
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
n=13 Participants
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
n=14 Participants
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
n=11 Participants
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
n=12 Participants
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
n=14 Participants
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Change From Baseline in Mixed Meal Tolerance Test (MMTMT) Stimulated C-peptide 2 Hour Area Under the Concentration-time Curve (AUC)
-32.357 min*nmol/L
Standard Deviation 27.7184
-25.171 min*nmol/L
Standard Deviation 28.9450
-21.682 min*nmol/L
Standard Deviation 24.5787
-34.393 min*nmol/L
Standard Deviation 25.6837
-16.909 min*nmol/L
Standard Deviation 19.1278

SECONDARY outcome

Timeframe: Baseline, Weeks 14, 27, 39, 69, 87, and 104 (pre-high protein drink and 15, 30, 60, 90, 120 minutes post-drink)

Population: Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.

Outcome measures

Outcome measures
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
n=15 Participants
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
n=16 Participants
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
n=15 Participants
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Change From Baseline for MMTT Stimulated C-peptide 2h AUC
Week 14
-19.396 min*nmol/L
Standard Deviation 23.7789
-0.444 min*nmol/L
Standard Deviation 18.8595
4.427 min*nmol/L
Standard Deviation 33.2220
-12.725 min*nmol/L
Standard Deviation 20.2051
3.317 min*nmol/L
Standard Deviation 21.1784
Change From Baseline for MMTT Stimulated C-peptide 2h AUC
Week 27
-30.709 min*nmol/L
Standard Deviation 21.2821
-17.826 min*nmol/L
Standard Deviation 21.0462
6.537 min*nmol/L
Standard Deviation 56.1336
-23.082 min*nmol/L
Standard Deviation 22.3027
-1.411 min*nmol/L
Standard Deviation 26.8550
Change From Baseline for MMTT Stimulated C-peptide 2h AUC
Week 39
-28.500 min*nmol/L
Standard Deviation 37.6682
-17.664 min*nmol/L
Standard Deviation 26.1729
-23.342 min*nmol/L
Standard Deviation 21.6945
-36.580 min*nmol/L
Standard Deviation 20.7765
-10.808 min*nmol/L
Standard Deviation 20.0078
Change From Baseline for MMTT Stimulated C-peptide 2h AUC
Week 69
-45.316 min*nmol/L
Standard Deviation 27.1563
-42.014 min*nmol/L
Standard Deviation 15.7239
-27.023 min*nmol/L
Standard Deviation 28.6920
-39.735 min*nmol/L
Standard Deviation 23.3488
-16.744 min*nmol/L
Standard Deviation 21.8947
Change From Baseline for MMTT Stimulated C-peptide 2h AUC
Week 87
-42.487 min*nmol/L
Standard Deviation 31.9418
-43.012 min*nmol/L
Standard Deviation 23.2403
-34.590 min*nmol/L
Standard Deviation 21.6148
-47.496 min*nmol/L
Standard Deviation 23.7717
-32.561 min*nmol/L
Standard Deviation 20.0826
Change From Baseline for MMTT Stimulated C-peptide 2h AUC
Week 104
-29.687 min*nmol/L
Standard Deviation 25.5941
-44.314 min*nmol/L
Standard Deviation 28.0612
-32.980 min*nmol/L
Standard Deviation 18.2765
-39.908 min*nmol/L
Standard Deviation 26.4652
-26.586 min*nmol/L
Standard Deviation 20.6803

SECONDARY outcome

Timeframe: Baseline, Weeks 14, 27, 39, 52, 69, 87, and 104

Population: Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.

Outcome measures

Outcome measures
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
n=15 Participants
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
n=16 Participants
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
n=15 Participants
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Change From Baseline for HbA1c Levels
Week 14
-0.68 percentage of change from baseline
Standard Deviation 2.108
-1.75 percentage of change from baseline
Standard Deviation 2.543
-1.16 percentage of change from baseline
Standard Deviation 1.683
-1.45 percentage of change from baseline
Standard Deviation 1.812
-2.64 percentage of change from baseline
Standard Deviation 2.452
Change From Baseline for HbA1c Levels
Week 27
-0.67 percentage of change from baseline
Standard Deviation 1.953
-1.38 percentage of change from baseline
Standard Deviation 2.799
-0.74 percentage of change from baseline
Standard Deviation 2.263
-0.89 percentage of change from baseline
Standard Deviation 2.740
-2.52 percentage of change from baseline
Standard Deviation 2.439
Change From Baseline for HbA1c Levels
Week 39
-0.58 percentage of change from baseline
Standard Deviation 2.098
-0.78 percentage of change from baseline
Standard Deviation 3.043
-0.40 percentage of change from baseline
Standard Deviation 1.495
-0.55 percentage of change from baseline
Standard Deviation 2.798
-1.52 percentage of change from baseline
Standard Deviation 2.473
Change From Baseline for HbA1c Levels
Week 52
-0.47 percentage of change from baseline
Standard Deviation 1.383
-0.55 percentage of change from baseline
Standard Deviation 3.437
-0.25 percentage of change from baseline
Standard Deviation 1.399
-0.51 percentage of change from baseline
Standard Deviation 2.504
-1.52 percentage of change from baseline
Standard Deviation 2.805
Change From Baseline for HbA1c Levels
Week 69
-0.01 percentage of change from baseline
Standard Deviation 1.630
-0.18 percentage of change from baseline
Standard Deviation 2.529
0.09 percentage of change from baseline
Standard Deviation 1.197
-0.33 percentage of change from baseline
Standard Deviation 2.532
-1.37 percentage of change from baseline
Standard Deviation 3.004
Change From Baseline for HbA1c Levels
Week 87
-0.54 percentage of change from baseline
Standard Deviation 1.310
-0.38 percentage of change from baseline
Standard Deviation 3.035
0.30 percentage of change from baseline
Standard Deviation 2.147
-0.26 percentage of change from baseline
Standard Deviation 2.608
-0.89 percentage of change from baseline
Standard Deviation 3.011
Change From Baseline for HbA1c Levels
Week 104
-0.76 percentage of change from baseline
Standard Deviation 1.419
-0.69 percentage of change from baseline
Standard Deviation 2.490
0.28 percentage of change from baseline
Standard Deviation 1.987
-0.10 percentage of change from baseline
Standard Deviation 2.890
-1.36 percentage of change from baseline
Standard Deviation 2.155

SECONDARY outcome

Timeframe: 104 weeks

Population: Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.

Severe hypoglycemia defined according the ADA Workgroup on Hypoglycemia definition, as follows: An event requiring assistance of another person to actively administer carbohydrate, glucagons, or other resuscitative actions.

Outcome measures

Outcome measures
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
n=15 Participants
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
n=16 Participants
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
n=15 Participants
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Number of Subjects With Overall Severe Hypoglycemic Episodes
1 episode
1 Participants
2 Participants
0 Participants
0 Participants
1 Participants
Number of Subjects With Overall Severe Hypoglycemic Episodes
2 episodes
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Subjects With Overall Severe Hypoglycemic Episodes
3 episodes
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 14, 27, 39, 52, 69, 87, and 104

Population: Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.

Outcome measures

Outcome measures
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
n=15 Participants
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
n=16 Participants
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
n=15 Participants
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Change From Baseline for Mean Daily Insulin Dose Requirements
Week 52
0.226 U/kg/day
Standard Deviation 0.5861
-0.037 U/kg/day
Standard Deviation 0.8720
-0.055 U/kg/day
Standard Deviation 0.2180
0.214 U/kg/day
Standard Deviation 0.5898
-0.320 U/kg/day
Standard Deviation 0.2906
Change From Baseline for Mean Daily Insulin Dose Requirements
Week 2
-0.146 U/kg/day
Standard Deviation 0.2044
-0.141 U/kg/day
Standard Deviation 0.2143
-0.205 U/kg/day
Standard Deviation 0.2194
-0.274 U/kg/day
Standard Deviation 0.1416
-0.158 U/kg/day
Standard Deviation 0.2828
Change From Baseline for Mean Daily Insulin Dose Requirements
Week 4
-0.147 U/kg/day
Standard Deviation 0.1405
-0.264 U/kg/day
Standard Deviation 0.1456
-0.201 U/kg/day
Standard Deviation 0.2058
-0.220 U/kg/day
Standard Deviation 0.1744
-0.150 U/kg/day
Standard Deviation 0.2788
Change From Baseline for Mean Daily Insulin Dose Requirements
Week 14
-0.239 U/kg/day
Standard Deviation 0.2301
-0.305 U/kg/day
Standard Deviation 0.1406
-0.092 U/kg/day
Standard Deviation 0.1442
-0.239 U/kg/day
Standard Deviation 0.1430
-0.118 U/kg/day
Standard Deviation 0.1114
Change From Baseline for Mean Daily Insulin Dose Requirements
Week 27
-0.040 U/kg/day
Standard Deviation 0.2313
-0.033 U/kg/day
Standard Deviation 0.4310
-0.090 U/kg/day
Standard Deviation 0.2117
-0.138 U/kg/day
Standard Deviation 0.2321
-0.135 U/kg/day
Standard Deviation 0.0607
Change From Baseline for Mean Daily Insulin Dose Requirements
Week 39
-0.040 U/kg/day
Standard Deviation 0.3222
0.146 U/kg/day
Standard Deviation 0.7900
-0.089 U/kg/day
Standard Deviation 0.2099
-0.158 U/kg/day
Standard Deviation 0.2552
-0.150 U/kg/day
Standard Deviation 0.1100
Change From Baseline for Mean Daily Insulin Dose Requirements
Week 69
0.192 U/kg/day
Standard Deviation 0.5491
0.213 U/kg/day
Standard Deviation 0.6097
0.142 U/kg/day
Standard Deviation 0.5981
0.016 U/kg/day
Standard Deviation 0.7005
-0.011 U/kg/day
Standard Deviation 0.2858
Change From Baseline for Mean Daily Insulin Dose Requirements
Week 87
0.517 U/kg/day
Standard Deviation 0
0.164 U/kg/day
Standard Deviation 0.5377
0.247 U/kg/day
Standard Deviation 0.6591
0.086 U/kg/day
Standard Deviation 0.5132
-0.044 U/kg/day
Standard Deviation 0.4264
Change From Baseline for Mean Daily Insulin Dose Requirements
Week 104
0.491 U/kg/day
Standard Deviation 0
-0.168 U/kg/day
Standard Deviation 0.4650
0.307 U/kg/day
Standard Deviation 0.3772
-0.015 U/kg/day
Standard Deviation 0.5626
0.303 U/kg/day
Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 14, 27, 39, 52, 69, 87, and 104

Population: Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.

For each visit, the mean daily glucose levels were calculated over the previous 3-7 days prior to the study visit from blood glucose levels recorded daily prior to meals and bedtime.

Outcome measures

Outcome measures
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
n=15 Participants
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
n=16 Participants
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
n=15 Participants
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
n=15 Participants
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime
Week 52
2.995 mmol/L
Standard Deviation 1.6703
3.067 mmol/L
Standard Deviation 2.9160
3.242 mmol/L
Standard Deviation 3.1636
2.723 mmol/L
Standard Deviation 4.3749
0.616 mmol/L
Standard Deviation 2.1868
Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime
Week 104
2.545 mmol/L
Standard Deviation 0
1.867 mmol/L
Standard Deviation 2.4532
2.390 mmol/L
Standard Deviation 1.5429
2.283 mmol/L
Standard Deviation 6.1064
2.431 mmol/L
Standard Deviation 1.4519
Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime
Week 2
2.223 mmol/L
Standard Deviation 3.6282
2.379 mmol/L
Standard Deviation 2.7555
1.848 mmol/L
Standard Deviation 1.1257
0.578 mmol/L
Standard Deviation 1.6824
0.178 mmol/L
Standard Deviation 1.5195
Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime
Week 4
2.343 mmol/L
Standard Deviation 2.3942
1.856 mmol/L
Standard Deviation 2.4750
2.106 mmol/L
Standard Deviation 1.3144
0.759 mmol/L
Standard Deviation 1.0403
-0.158 mmol/L
Standard Deviation 1.4665
Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime
Week 14
2.812 mmol/L
Standard Deviation 2.5953
2.200 mmol/L
Standard Deviation 2.1283
2.852 mmol/L
Standard Deviation 3.0376
2.337 mmol/L
Standard Deviation 3.9732
-0.053 mmol/L
Standard Deviation 1.4368
Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime
Week 27
1.782 mmol/L
Standard Deviation 1.7921
2.252 mmol/L
Standard Deviation 2.8173
2.446 mmol/L
Standard Deviation 3.2355
3.471 mmol/L
Standard Deviation 3.1043
0.577 mmol/L
Standard Deviation 2.1475
Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime
Week 39
1.347 mmol/L
Standard Deviation 2.0674
3.848 mmol/L
Standard Deviation 2.2236
4.471 mmol/L
Standard Deviation 2.7390
3.681 mmol/L
Standard Deviation 4.0469
1.421 mmol/L
Standard Deviation 2.1779
Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime
Week 69
2.182 mmol/L
Standard Deviation 1.3352
18.224 mmol/L
Standard Deviation 41.1471
4.324 mmol/L
Standard Deviation 4.4173
3.677 mmol/L
Standard Deviation 3.7397
1.467 mmol/L
Standard Deviation 4.2254
Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime
Week 87
3.354 mmol/L
Standard Deviation 2.9550
3.101 mmol/L
Standard Deviation 2.3859
3.234 mmol/L
Standard Deviation 2.1516
3.835 mmol/L
Standard Deviation 3.6760
4.863 mmol/L
Standard Deviation 2.5173

Adverse Events

Alpha1-PI 180 mg/kg/wk, 26 Weeks

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

180 mg/kg/wk Alpha1-PI, 13 Weeks

Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths

90 mg/kg/wk Alpha1-PI, 26 Weeks

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

90 mg/kg/wk Alpha1-PI, 13 Weeks

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
n=15 participants at risk
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
n=16 participants at risk
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
n=14 participants at risk
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
n=15 participants at risk
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
n=15 participants at risk
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Psychiatric disorders
Completed suicide
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.

Other adverse events

Other adverse events
Measure
Alpha1-PI 180 mg/kg/wk, 26 Weeks
n=15 participants at risk
180 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 180 mg/kg Alpha1-PI
180 mg/kg/wk Alpha1-PI, 13 Weeks
n=16 participants at risk
180 mg/kg weekly infusions of Alpha1-PI for 13 weeks. 180 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 26 Weeks
n=14 participants at risk
90 mg/kg weekly infusions of Alpha1-PI for 26 weeks. 90 mg/kg Alpha1-PI
90 mg/kg/wk Alpha1-PI, 13 Weeks
n=15 participants at risk
90 mg/kg weekly infusions of Alpha1-PI for 13 weeks 90 mg/kg Alpha1-PI
Placebo
n=15 participants at risk
Weekly infusions of placebo for 13 or 26 weeks. Placebo
Blood and lymphatic system disorders
Lymphadenopathy
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Cardiac disorders
Palpitations
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Cardiac disorders
Sinus arrhythmia
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Ear and labyrinth disorders
Inner ear inflammation
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Endocrine disorders
Hypothyroidism
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Abdominal pain
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Abdominal pain upper
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
12.5%
2/16 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Aphthous stomatitis
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Constipation
13.3%
2/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Diarrhoea
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
12.5%
2/16 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Gingival pain
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Irritable bowel syndrome
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Nausea
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
18.8%
3/16 • Number of events 3 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
13.3%
2/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Tooth impacted
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
12.5%
2/16 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Gastrointestinal disorders
Vomiting
13.3%
2/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
18.8%
3/16 • Number of events 4 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
26.7%
4/15 • Number of events 4 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Chest discomfort
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Fatigue
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Feeling cold
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Hypertrophy
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Infusion site bruising
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Infusion site extravasation
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Injection site bruising
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Localised oedema
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Malaise
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Medical device complication
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Non-cardiac chest pain
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Pain
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Pyrexia
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
General disorders
Vessel puncture site bruise
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Immune system disorders
Hypersensitivity
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Immune system disorders
Multiple allergies
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Immune system disorders
Seasonal allergy
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Cellulitis
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Croup infectious
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Fungal infection
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Gastroenteritis
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
12.5%
2/16 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
14.3%
2/14 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Gastroenteritis viral
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Genitourinary tract infection
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Infectious mononucleosis
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Influenza
13.3%
2/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Nasopharyngitis
13.3%
2/15 • Number of events 3 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
21.4%
3/14 • Number of events 5 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
20.0%
3/15 • Number of events 4 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
13.3%
2/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Onychomycosis
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Paronychia
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Pharyngitis
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Pharyngitis streptococcal
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Rhinitis
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Sinusitis
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
14.3%
2/14 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Tooth infection
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Upper respiratory tract infection
13.3%
2/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
25.0%
4/16 • Number of events 9 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
28.6%
4/14 • Number of events 6 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
20.0%
3/15 • Number of events 4 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Urinary tract infection
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Infections and infestations
Viral infection
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Injury, poisoning and procedural complications
Contusion
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
21.4%
3/14 • Number of events 3 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Injury, poisoning and procedural complications
Injury
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Injury, poisoning and procedural complications
Joint dislocation
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Injury, poisoning and procedural complications
Ligament sprain
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Injury, poisoning and procedural complications
Muscle strain
6.7%
1/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Injury, poisoning and procedural complications
Stress fracture
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Investigations
Arthroscopy
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Investigations
Neutrophil count decreased
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Musculoskeletal and connective tissue disorders
Arthralgia
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Musculoskeletal and connective tissue disorders
Pain in extremity
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Nervous system disorders
Dizziness
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Nervous system disorders
Dysgeusia
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Nervous system disorders
Headache
20.0%
3/15 • Number of events 3 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
18.8%
3/16 • Number of events 3 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
28.6%
4/14 • Number of events 7 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Nervous system disorders
Hypoaesthesia
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Nervous system disorders
Migraine
6.7%
1/15 • Number of events 3 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Nervous system disorders
Myoclonus
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Nervous system disorders
Sinus headache
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Nervous system disorders
Syncope
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Psychiatric disorders
Depression
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Reproductive system and breast disorders
Breast pain
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Respiratory, thoracic and mediastinal disorders
Cough
13.3%
2/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
13.3%
2/15 • Number of events 4 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 3 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
13.3%
2/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
13.3%
2/15 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Skin and subcutaneous tissue disorders
Acne
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
12.5%
2/16 • Number of events 2 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Skin and subcutaneous tissue disorders
Dermal cyst
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Skin and subcutaneous tissue disorders
Ingrowing nail
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Skin and subcutaneous tissue disorders
Lipohypertrophy
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Skin and subcutaneous tissue disorders
Rash generalised
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
7.1%
1/14 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Skin and subcutaneous tissue disorders
Skin irritation
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Skin and subcutaneous tissue disorders
Swelling face
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.2%
1/16 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Surgical and medical procedures
Tooth extraction
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
Surgical and medical procedures
Wisdom teeth removal
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/16 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/14 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
0.00%
0/15 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.
6.7%
1/15 • Number of events 1 • All AEs occurring after subject consent through Week 52 were collected
One subject in the 90 mg/kg/wk Alpha-1 PI, 26 Weeks group prematurely withdrew from the study, did not receive study drug, and was excluded from the safety population.

Additional Information

Kimberly Steinmann, MD

Grifols Therapeutics LLC

Phone: 919-308-5444

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place