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Low INR to Minimize bleeding with mechanical valves Trial

The objective in the vanguard phase of the LIMIT trial is to assess the feasibility of recruiting 400 subjects over approximately 3 years at 5 centres. The objectives in the full trial are to evaluate the safety and efficacy of a common, lower INR…

A Prospective Phase III Multi-center, 2-Year Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of *Kamada-AAT for Inhalation* 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% <= FEV1 <= 80% of predicted; FEV1/SVC <= 70%), Followed by a 2-Year Open-Label Extension

Primary Objective (Double Blind)To assess the efficacy of Kamada-AAT for Inhalation administered at a dose of 80 mg daily versus (vs) placebo, with efficacy measured by FEV1 post bronchodilator change from baseline at 104 weeks. OLE Objectives1. To…