Clinical Trial: 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: OPuS-2: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX4161 for 12 Weeks as an Oral Prophylaxis Treatmen
Brief Summary: This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in subjects with hereditary angioedema (HAE). Eligible subjects will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.
Detailed Summary:
Sponsor: BioCryst Pharmaceuticals
Current Primary Outcome: The mean acute angioedema attack rate [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of attack-free days [ Time Frame: 12 weeks ]
- Number of subjects who are attack-free [ Time Frame: 12 weeks ]
- Disease activity, as measured by the 84-day Angioedema Activity Score [ Time Frame: 12 weeks ]
- Quality of Life, as measured by the Angioedema Quality of Life Questionnaire [ Time Frame: 12 weeks ]
- Incidence and severity of adverse events and laboratory abnormalities [ Time Frame: 12 weeks ]
- Quality of Life, as measured by the EuroQoL five-dimensional, 5-level Questionnaire [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: BioCryst Pharmaceuticals
Dates:
Date Received: November 24, 2014
Date Started: November 2014
Date Completion:
Last Updated: February 15, 2016
Last Verified: February 2016
