Emphysema Clinical Trial
Official title:
A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema
This is a randomised , placebo controlled, double blind , multicentre, Phase II/III study evaluating the safety and efficacy of Kamada AAT for inhalation in patients with Emphysema caused by Alpha-1 Antitrypsin (AAT) deficiency.
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 Emphysema. 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.
Three blinded interim analyses have shown that there are no safety issues and no concerns
regarding tolerability.
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