CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 387 enrolled
Drug / intervention
BCX7353drug
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.

Search/NCT03472040
NCT03472040Phase 3Completed

An Open-label Study to Evaluate the Long-term Safety of Daily Oral BCX7353 in Subjects With Type I and II Hereditary Angioedema

BioCryst Pharmaceuticals·interventional·Posted Mar 21, 2018·Updated Jun 18, 2023

In Brief

A Phase 3 clinical trial evaluating BCX7353 for Hereditary Angioedema and 2 related conditions. Completed, enrolled 387 participants across 87 sites in 20 countries.

Detailed Summary

This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, New Zealand, North Macedonia, Poland, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 21, 2018
Enrollment StartFeb 16, 2018
Primary CompletionApr 27, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 8.3 years ago

Interventions

BCX7353drug

BCX7353 mg oral capsules administered once daily