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Kamada Announces Initiation of Phase 2 Clinical Trial with Intravenous Alpha-1 Antitrypsin for the Prevention of Lung Transplant Rejection

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Additional Relevant Details The Phase 2 trial is a randomized, open-label, single-site study of 30 lung transplant recipients to evaluate the safety and efficacy of IV AAT on top of standard-of-care (SOC) versus SOC. The study is randomized 2:1 with 20 patients in the treatment group receiving IV AAT treatment every other day for 14 days, then once every two weeks until week eight, followed thereafter by monthly treatments. The 10 patients in the control group will be treated with SOC, which includes systemic corticosteroids and immunosuppressants. Following one year of AAT treatment, there will be a one-year follow-up.
 The primary endpoints of the study include safety and tolerability, the incidence of acute lung transplant rejection and changes in Forced Expiratory Volume (FEV1) from baseline and overall effect (a measure of Bronchiolitis Obliterans (chronic rejection). Additional endpoints measured will include various inflammatory biomarkers and functional capacity. The study is being conducted at Rabin Medical Center - Beilinson Hospital in Israel and is being led by principal investigator, Prof. Kramer. Dr. Kramer completed several fellowships in the U.S. in pulmonary care and lung transplantation, and has published many articles in leading scientific publications. 
http://www.kamada.co...
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Catalyst Date
Occurred on:
Apr 07, 2016
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Related Keywords Phase 2 Trial, Intravenous Alpha-1 Antitrypsin, Lung Transplat Rejection, Bronchiolitis Obliterans, Chronic Rejection, Systemic Corticosteroids, Immunosuppressants, Aat Treatment