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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Double-Blind Comparison of an Alpha-1 Proteinase Inhibitor (Kamada API) With a Currently Marketed API Product in Individuals With Alpha-1

Brief 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.

Detailed Summary:

Alpha-1 Antitrypsin Deficiency, also called Alpha-1-Proteinase Inhibitor (API) deficiency, is a genetic disorder characterized by the production of an abnormal amount of AAT protein and reduced circulating levels of this protein. Subjects with AAT deficiency are at increased risk for developing chronic obstructive pulmonary disease (COPD). It is believed that this is the result of the chronic activity of elastase released by cells continually present in the lungs in low numbers.

This study is a randomized, double-blind comparison of Kamada API, an Alpha-1-Proteinase Inhibitor with a currently marketed API product.

Sponsor: Kamada, Ltd.

Current Primary Outcome: Efficacy

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety

Original Secondary Outcome: Same as current

Information By: Kamada, Ltd.

Dates:
Date Received: April 12, 2007
Date Started: March 2007
Date Completion:
Last Updated: October 16, 2007
Last Verified: October 2007