Clinical Trial

Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

Study acronym: APeX-A
Enrolling by Invitation Phase 3
View on ClinicalTrials.gov →
Summary
This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-06-14; most recent amendment 2025-12-19.
Status change: Active, Not Recruiting → Enrolling by Invitation 2025-12-19
Status change: Not Yet Recruiting → Active, Not Recruiting 2022-03-02
Trial Details
NCT Number NCT04933721
Lead Sponsor BioCryst Pharmaceuticals
Conditions Hereditary Angioedema, HAE
Enrollment 139 participants
Start Date 2021-07-23
Primary Completion 2031-08 (estimated)
Study Completion 2031-08 (estimated)
Updated on ClinicalTrials.gov 2025-12-23