At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 110 enrolled
Drug / intervention
BCX4161 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Treatment for Attacks of Hereditary Angioedema
In Brief
A Phase 3 clinical trial evaluating BCX4161 and Placebo for Hereditary Angioedema and HAE. Completed, enrolled 110 participants across 40 sites in 8 countries.
Detailed Summary
This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in participants with hereditary angioedema (HAE). Eligible participants 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema, HAE
CountriesBelgium, Canada, France, Germany, Hungary, Italy, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartDec 2014
Primary CompletionJan 2016
TodayJul 2026
First PostedDec 1, 2014
Enrollment StartDec 17, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 11.6 years ago
Interventions
BCX4161drug
Placebodrug