GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
NCT ID: NCT02525861 Phase: PHASE3 Status: COMPLETED Enrollment: 34 Completion: 2020-07-29
Conditions
Alpha1-antitrypsin Deficiency
Interventions
GLASSIA
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.
Primary Outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Potentially Related to Presence of Particle Load in the GLASSIA Solution