Alpha 1-Antitrypsin Deficiency Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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