NCT00460096

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kamada, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Alpha 1-Antitrypsin Deficiency

Interventions

Type	Name	Description
DRUG	Kamada-API

Timeline

• Start date: 2007-03-01
• Completion: 2007-09-01
• First posted: 2007-04-13
• Last updated: 2007-10-17

Locations

3 sites across 1 country: United States