Clinical Trial: Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2a Double-Blind Placebo-Controlled 2-Period Crossover Study to Evaluate the Safety and Efficacy of BCX4161 as a Prophylactic Treatment to Reduce the Frequency of Attacks in Subjects With Hered
Brief Summary: The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.
Detailed Summary:
Sponsor: BioCryst Pharmaceuticals
Current Primary Outcome: Number of acute angioedema attacks [ Time Frame: Over 28 days of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence and severity of adverse events and laboratory abnormalities [ Time Frame: Over 28 days of treatment ]
- Number of attack free days [ Time Frame: Over 28 days of treatment ]
- Angioedema Quality of Life scores [ Time Frame: Over 28 days of treatment ]
- Angioedema activity scores [ Time Frame: Over 28 days of treatment ]
Original Secondary Outcome: Same as current
Information By: BioCryst Pharmaceuticals
Dates:
Date Received: November 5, 2013
Date Started: November 2013
Date Completion:
Last Updated: August 14, 2014
Last Verified: August 2014
