NCT02525861

GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study

A Phase 3/4 Study to Evaluate the Safety, Immunogenicity, and Effects on the Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid Following Glassia Therapy in A1PI-Deficient Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is 2-fold: (1) to evaluate the safety and potential immunogenicity of GLASSIA following intravenous (IV) administration via in-line filtration; and (2) to assess the effects of GLASSIA augmentation therapy on the levels of A1PI and various biomarkers in the epithelial lining fluid (ELF) following intravenous (IV) administration at a dosage of 60 milligrams per kilogram (mg/kg) Body weight (BW)/week active alpha1-proteinase inhibitor (A1PI) protein for 25 weeks in participants with emphysema due to congenital A1PI deficiency.

Conditions

• Alpha1-antitrypsin Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	GLASSIA	Participants will receive weekly IV infusions of GLASSIA at 60 mg/kg BW active A1PI protein administered at a rate of 0.2 mL/kg/min for 25 weeks (25 planned infusions) via an IV administration.

Timeline

• Start date: 2016-03-08
• Primary completion: 2020-07-29
• Completion: 2020-07-29
• First posted: 2015-08-18
• Last updated: 2021-10-14
• Results posted: 2021-10-14

Locations

18 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study