A Phase 4 interventional study of Alpha1-proteinase inhibitor and Placebo: Human albumin 2.5% in Alpha1-antitrypsin Deficiency and Healthy Volunteers, sponsored by Baxalta now part of Shire. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by Baxalta now part of Shire · Phase 4, Interventional, and Treatment
The purpose of this study was to generate sufficient safety and tolerability information in support of an increase in the infusion rate of intravenous GLASSIA in the prescribing information from 0.04 to 0.2 mL/kg/min.
To achieve proper masking, 30 participants were randomly assigned to receive either GLASSIA at 0.04 mL/kg/min with a simultaneous administration of placebo (2.5% human albumin in normal saline) at 0.2 mL/kg/min (Cohort 1) or GLASSIA at 0.2 mL/kg/min with a simultaneous administration of placebo at 0.04 mL/kg/min (Cohort 2) on Day 1.
Two weeks later (Day 15), the same participants received the second infusion with the opposite rate of GLASSIA infusion and the corresponding masking placebo infusion.
94 studies on the registry are indexed under Alpha 1-Antitrypsin Deficiency; 5 are open to participants now.
This study's enrollment of 30 is above the median of 27 across 58 interventional studies indexed under Alpha 1-Antitrypsin Deficiency.
Browse Alpha 1-Antitrypsin Deficiency studies →Baxalta now part of Shire is the lead sponsor of 110 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Biological: Alpha1-proteinase inhibitor · Biological: Placebo: Human albumin 2.5%
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
Biological: Alpha1-proteinase inhibitor · Biological: Placebo: Human albumin 2.5%
GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.
Also known as: GLASSIA
Intravenous administration
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)
Time frame: Day 1 and Day 15
Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion
Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment
Time frame: Within 1 hour of infusion completion
Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion
Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment
Time frame: Within 24 hours of the end of infusion
Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion
Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment
Time frame: Within 72 hours of the end of infusion
Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion
Number of AEs that occurred during an infusion and were deemed related to study product administration
Time frame: Day 1 and Day 15
Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion
Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration
Time frame: 72 hours post infusion to 14 days post infusion
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
Number of participants with seroconversion
Time frame: 105 days
Recruitment was conducted in the U.S at 1 study site. The first participant was enrolled in July 2012.
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
| Infusions | GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min | GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min |
|---|---|---|
| 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 | 0 |
Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment
| Infusions | GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min | GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min |
|---|---|---|
| Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion | 3 | 1 |
Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment
| Infusions | GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min | GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min |
|---|---|---|
| Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion | 5 | 3 |
Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment
| Infusions | GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min | GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min |
|---|---|---|
| Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion | 7 | 5 |
Number of AEs that occurred during an infusion and were deemed related to study product administration
| adverse events | GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min | GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min |
|---|---|---|
| Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion | 1 | 0 |
Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration
| adverse events | GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min | GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min |
|---|---|---|
| Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion | 0 | 0 |
Number of participants with seroconversion
| participants | All Study Participants |
|---|---|
| HAV | 0 |
| HBV | 0 |
| HCV | 0 |
| PVB19 | 0 |
| HIV | 0 |
Collected over Throughout the study period of 105 days per participant. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GLASSIA Infusion Rate- 0.04 mL/kg/Min | — | 0/30 (0%) | 8/30 (26.7%) |
| GLASSIA Infusion Rate- 0.2 mL/kg/Min | — | 0/30 (0%) | 4/30 (13.3%) |
| Event | GLASSIA Infusion Rate- 0.04 mL/kg/Min | GLASSIA Infusion Rate- 0.2 mL/kg/Min |
|---|---|---|
| HeadacheNervous system disorders | 6/30 | 3/30 |
| Back PainMusculoskeletal and connective tissue disorders | 1/30 | 2/30 |
| Pain In ExtremityMusculoskeletal and connective tissue disorders | 2/30 | 0/30 |
| DizzinessNervous system disorders | 2/30 | 1/30 |
Safety Analysis Set
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 27 ± 8 | 29 ± 13 | 28 ± 11 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 12 | 11 | 23 |
| Region of Enrollment(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Alpha 1-Antitrypsin Deficiency→
Baxalta now part of Shire