Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency (Kamada API)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|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 Antitrypsin Deficiency|
|Study Start Date:||March 2007|
|Study Completion Date:||September 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460096
|United States, Colorado|
|National Jewish Medical and Research Center|
|Denver, Colorado, United States, 80206|
|United States, Florida|
|University of Florida School of Medicine|
|Gainesville, Florida, United States, 32610|
|United States, Texas|
|The University of Texas Health Center at Tyler|
|Tyler, Texas, United States, 75708-3154|
|Principal Investigator:||Robert A Sandhaus, M.D.||National Jewish Health|