Clinical Trial

Experimental Treatment for Patients with Emphysema

Study Description

GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT02525861

ParticipAid ID

7e53Ab