Trial Outcomes & Findings for GLASSIA Infusion Rate Study (NCT NCT01651351)
NCT ID: NCT01651351
Last Updated: 2021-05-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Day 1 and Day 15
Results posted on
2021-05-25
Participant Flow
Recruitment was conducted in the U.S at 1 study site. The first participant was enrolled in July 2012.
Thirty five healthy potential participants were enrolled at the clinical study site. Four were screen failures, and one was a back up participant who did not participate. Therefore, 30 participants were randomized.
Participant milestones
| Measure |
Cohort 1
Day 1: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Day 15: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration. Placebo: Human albumin 2.5%: Intravenous administration
|
Cohort 2
Day 1: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Day 15: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration. Placebo: Human albumin 2.5%: Intravenous administration
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GLASSIA Infusion Rate Study
Baseline characteristics by cohort
| Measure |
Cohort 1
n=15 Participants
Day 1: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Day 15: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Placebo: Human albumin 2.5%: Intravenous administration
|
Cohort 2
n=15 Participants
Day 1: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Day 15: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Placebo: Human albumin 2.5%: Intravenous administration
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 8 • n=99 Participants
|
29 years
STANDARD_DEVIATION 13 • n=107 Participants
|
28 years
STANDARD_DEVIATION 11 • 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
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 15Population: Safety Analysis Set
Outcome measures
| Measure |
GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min
n=30 Participants
|
GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
n=30 Participants
|
|---|---|---|
|
Number of Infusions Associated With a Reduction in Infusion Rate or Discontinuation of Infusion Due to an Adverse Event (Regardless of Adverse Event Causality Assessment)
|
0 Infusions
|
0 Infusions
|
SECONDARY outcome
Timeframe: Within 1 hour of infusion completionPopulation: Safety Analysis Set
Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment
Outcome measures
| Measure |
GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min
n=30 Participants
|
GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
n=30 Participants
|
|---|---|---|
|
Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion
|
3 Infusions
|
1 Infusions
|
SECONDARY outcome
Timeframe: Within 24 hours of the end of infusionPopulation: Safety Analysis Set
Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment
Outcome measures
| Measure |
GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min
n=30 Participants
|
GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
n=30 Participants
|
|---|---|---|
|
Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion
|
5 Infusions
|
3 Infusions
|
SECONDARY outcome
Timeframe: Within 72 hours of the end of infusionPopulation: Safety Analysis Set
Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment
Outcome measures
| Measure |
GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min
n=30 Participants
|
GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
n=30 Participants
|
|---|---|---|
|
Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion
|
7 Infusions
|
5 Infusions
|
SECONDARY outcome
Timeframe: Day 1 and Day 15Population: Safety Analysis Set
Number of AEs that occurred during an infusion and were deemed related to study product administration
Outcome measures
| Measure |
GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min
n=30 Participants
|
GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
n=30 Participants
|
|---|---|---|
|
Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion
|
1 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: 72 hours post infusion to 14 days post infusionPopulation: Safety Analysis Set
Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration
Outcome measures
| Measure |
GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min
n=30 Participants
|
GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
n=30 Participants
|
|---|---|---|
|
Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion
|
0 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: 105 daysPopulation: Safety Analysis Set
Number of participants with seroconversion
Outcome measures
| Measure |
GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min
n=30 Participants
|
GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
|
|---|---|---|
|
Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA
HAV
|
0 participants
|
—
|
|
Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA
HBV
|
0 participants
|
—
|
|
Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA
HCV
|
0 participants
|
—
|
|
Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA
PVB19
|
0 participants
|
—
|
|
Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA
HIV
|
0 participants
|
—
|
Adverse Events
GLASSIA Infusion Rate- 0.04 mL/kg/Min
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
GLASSIA Infusion Rate- 0.2 mL/kg/Min
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GLASSIA Infusion Rate- 0.04 mL/kg/Min
n=30 participants at risk
Participants who received simultaneous infusions of: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min
|
GLASSIA Infusion Rate- 0.2 mL/kg/Min
n=30 participants at risk
Participants who received simultaneous infusions of: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.3%
1/30 • Number of events 1 • Throughout the study period of 105 days per participant
|
6.7%
2/30 • Number of events 2 • Throughout the study period of 105 days per participant
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.7%
2/30 • Number of events 2 • Throughout the study period of 105 days per participant
|
0.00%
0/30 • Throughout the study period of 105 days per participant
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • Number of events 7 • Throughout the study period of 105 days per participant
|
10.0%
3/30 • Number of events 5 • Throughout the study period of 105 days per participant
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30 • Number of events 2 • Throughout the study period of 105 days per participant
|
3.3%
1/30 • Number of events 1 • Throughout the study period of 105 days per participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI may not publish without the prior written consent of Sponsor
- Publication restrictions are in place
Restriction type: OTHER