At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 30 enrolled
Drug / intervention
Alpha1-proteinase inhibitor +1 morebiological
Likely dose
Alpha1-proteinase inhibitor 50 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4 Double-Blind Study to Assess the Safety and Tolerability of Intravenous Administration of GLASSIA in Healthy Adult Volunteers
In Brief
A Phase 4 clinical trial evaluating Alpha1-proteinase inhibitor and Placebo: Human albumin 2.5% for Alpha1-antitrypsin Deficiency and Healthy Volunteers. Completed, enrolled 30 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha1-antitrypsin Deficiency, Healthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartJul 2012
Primary CompletionJan 2013
TodayJul 2026
First PostedJul 27, 2012
Enrollment StartJul 31, 2012
Primary CompletionJan 16, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.9 years ago
Interventions
Alpha1-proteinase inhibitorbiological
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%biological
Intravenous administration