Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency

Summary

The primary purpose of this Phase II/III study is to demonstrate that Kamada-API, a new API concentrate manufactured by Kamada Ltd., is comparable to a currently marketed API product.

Timeline

Start

2007-03

Primary completion

—

Completion

2007-09

Outcome

Met primary endpoint

paper Non-inferiority of GLASSIA to PROLASTIN was demonstrated by remaining within the lower bounds of the confidence intervals (≤3 μM) for both antigenic and functional A1PI. PMID 23822603 ↗

Publications

• Sandhaus RA, Stocks J, Rouhani FN, Brantly M, Strauss P. Biochemical efficacy and safety of a new, ready-to-use, liquid alpha-1-proteinase inhibitor, GLASSIA (alpha1-proteinase inhibitor (human), intravenous). COPD. 2014 Feb;11(1):17-25. doi: 10.3109/15412555.2013.804500. Epub 2013 Jul 3.

Drugs

Indications