At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 121 enrolled
Drug / intervention
BCX7353 capsules +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.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema
In Brief
A Phase 3 clinical trial evaluating BCX7353 capsules and Placebo oral capsule for Hereditary Angioedema and HAE. Completed, enrolled 121 participants across 47 sites in 11 countries.
Detailed Summary
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema, HAE
CountriesAustria, Canada, Czechia, France, Germany, Hungary, North Macedonia, Romania, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartFeb 2018
First PostedApr 2018
Primary CompletionApr 2019
Study CompletionApr 2022
TodayJul 2026
First PostedApr 3, 2018
Enrollment StartFeb 6, 2018
Primary CompletionApr 10, 2019
Study CompletionApr 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.2 years ago
Interventions
BCX7353 capsulesdrug
BCX7353 oral capsules administered once daily
Placebo oral capsuledrug
Matching oral capsules administered once daily