Clinical Trial: International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 De
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Kamada, Ltd.
Current Primary Outcome: Exacerbation events and lung density [ Time Frame: Approximately 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse Events [ Time Frame: Approximately 1 year ]
- Vital Signs [ Time Frame: Approximately 1 year ]
- Physical Examination [ Time Frame: Approximately 1 year ]
- ECG [ Time Frame: Approximately 1 year ]
- Lung function [ Time Frame: Approximately 1 year ]
- Laboratory Evaluations [ Time Frame: Approximately 1 year ]
Original Secondary Outcome: Same as current
Information By: Kamada, Ltd.
Dates:
Date Received: September 15, 2010
Date Started: December 2009
Date Completion:
Last Updated: June 8, 2016
Last Verified: April 2016
