drugset / Trial / NCT00460096

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

NCT00460096

Phase 2/3 Completed 50 enrolled Kamada, Ltd.
RandomizedCrossoverDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpha 1-Antitrypsin Protein / enzyme biologic Intravenous