Trial Outcomes & Findings for Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP (NCT NCT00220727)
NCT ID: NCT00220727
Last Updated: 2016-04-27
Results Overview
Free hemoglobin as a measure to assess hemolysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
24 hours after treatment
Results posted on
2016-04-27
Participant Flow
Single-center, open label study in patients with a confirmed diagnosis of Idiopathic Thrombocytopenic Purpura (ITP).
Participant milestones
| Measure |
IGIV-C, 10% - 0.08/0.14 mL/kg/Min
Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)
|
IGIV-C, 10% - 0.14/0.08 mL/kg/Min
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)
|
|---|---|---|
|
First Infusion (Week 0)
STARTED
|
4
|
4
|
|
First Infusion (Week 0)
COMPLETED
|
4
|
4
|
|
First Infusion (Week 0)
NOT COMPLETED
|
0
|
0
|
|
Second Infusion (Week <6)
STARTED
|
4
|
4
|
|
Second Infusion (Week <6)
COMPLETED
|
3
|
4
|
|
Second Infusion (Week <6)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
IGIV-C, 10% - 0.08/0.14 mL/kg/Min
Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)
|
IGIV-C, 10% - 0.14/0.08 mL/kg/Min
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)
|
|---|---|---|
|
Second Infusion (Week <6)
Pt did not meet study requirement
|
1
|
0
|
Baseline Characteristics
Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP
Baseline characteristics by cohort
| Measure |
IGIV-C, 10% - 0.08/0.14 mL/kg/Min
n=4 Participants
Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)
|
IGIV-C, 10% - 0.14/0.08 mL/kg/Min
n=4 Participants
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
47.75 years
STANDARD_DEVIATION 15.78 • n=99 Participants
|
47.50 years
STANDARD_DEVIATION 14.89 • n=107 Participants
|
47.63 years
STANDARD_DEVIATION 14.20 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hours after treatmentFree hemoglobin as a measure to assess hemolysis.
Outcome measures
| Measure |
IGIV-C, 10% (0.08 mL/kg/Min)
n=7 Participants
Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)
|
IGIV-C, 10% (0.14 mL/kg/Min)
n=7 Participants
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)
|
|---|---|---|
|
Free Hemoglobin
|
13.057 g/dL
Standard Deviation 1.778
|
12.371 g/dL
Standard Deviation 2.644
|
PRIMARY outcome
Timeframe: 24 hrs after treatmentHematocrit as a measure to assess hemolysis
Outcome measures
| Measure |
IGIV-C, 10% (0.08 mL/kg/Min)
n=7 Participants
Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)
|
IGIV-C, 10% (0.14 mL/kg/Min)
n=7 Participants
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)
|
|---|---|---|
|
Hematocrit
|
36.80 percentage of blood
Standard Deviation 4.711
|
35.043 percentage of blood
Standard Deviation 6.793
|
PRIMARY outcome
Timeframe: 24 hrs after treatmentRed blood cells as a measure to assess hemolysis
Outcome measures
| Measure |
IGIV-C, 10% (0.08 mL/kg/Min)
n=7 Participants
Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)
|
IGIV-C, 10% (0.14 mL/kg/Min)
n=7 Participants
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)
|
|---|---|---|
|
Red Blood Cells
|
4.1514 10^12 cells/L
Standard Deviation .4820
|
4.0786 10^12 cells/L
Standard Deviation 0.8258
|
PRIMARY outcome
Timeframe: 24 hours Post infusion and Day 7Outcome measures
| Measure |
IGIV-C, 10% (0.08 mL/kg/Min)
n=6 Participants
Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)
|
IGIV-C, 10% (0.14 mL/kg/Min)
n=7 Participants
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)
|
|---|---|---|
|
Change From Baseline in Platelet Levels
Day 7
|
76 Giga/L
Standard Deviation 138.35
|
118.7 Giga/L
Standard Deviation 165.80
|
|
Change From Baseline in Platelet Levels
Baseline
|
29.50 Giga/L
Standard Deviation 28.47
|
6.86 Giga/L
Standard Deviation 3.39
|
|
Change From Baseline in Platelet Levels
24 hours post infusion
|
21.17 Giga/L
Standard Deviation 35.49
|
42.29 Giga/L
Standard Deviation 12.41
|
SECONDARY outcome
Timeframe: 48 hours after treatmentOutcome measures
| Measure |
IGIV-C, 10% (0.08 mL/kg/Min)
n=3 Participants
Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)
|
IGIV-C, 10% (0.14 mL/kg/Min)
n=4 Participants
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)
|
|---|---|---|
|
Number of Subjects With Infusion Related Adverse Events
|
2 participants
|
3 participants
|
Adverse Events
IGIV-C, 10% - 0.08 mL/kg/Min
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
IGIV-C, 10% - 0.14 mL/kg/Min
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IGIV-C, 10% - 0.08 mL/kg/Min
n=8 participants at risk
IGIV-C (0.08 mL/kg/min);
|
IGIV-C, 10% - 0.14 mL/kg/Min
n=7 participants at risk
IGIV-C (0.14 mL/kg/min);
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distention
|
12.5%
1/8
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8
|
14.3%
1/7
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
14.3%
1/7
|
|
Nervous system disorders
Headache
|
62.5%
5/8
|
57.1%
4/7
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
12.5%
1/8
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
12.5%
1/8
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
2/8
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
25.0%
2/8
|
28.6%
2/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator will be free to disclose at scientific meetings and to publish in the scientific literature data resulting from these trials. A copy of any manuscript must be sent to sponsor for review at least 1 month prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER