NCT01651351

GLASSIA Infusion Rate Study

A Phase 4 Double-Blind Study to Assess the Safety and Tolerability of Intravenous Administration of GLASSIA in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Alpha1-antitrypsin Deficiency
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	Placebo: Human albumin 2.5%	Intravenous administration

Timeline

• Start date: 2012-07-31
• Primary completion: 2013-01-16
• Completion: 2013-01-16
• First posted: 2012-07-27
• Last updated: 2021-05-25
• Results posted: 2014-05-29

Locations

1 site across 1 country: United States