GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2016
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.
Epistemonikos ID: 28c8961a8ea188a4f660aae53a103a9350750eb4
First added on: May 12, 2024