Clinical Trial

Berotralstat Treatment in Children With Hereditary Angioedema

Study acronym: APeX-P
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and effectiveness of berotralstat to determine the appropriate weight-based dose for pediatric participants 2 to \< 12 years of age for prophylactic treatment to prevent attacks of hereditary angioedema (HAE).
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2022-07-08; most recent amendment 2026-02-06.
Status change: Recruiting → Active, Not Recruiting 2024-03-12
Status change: Not Yet Recruiting → Recruiting 2022-10-21
Trial Details
NCT Number NCT05453968
Lead Sponsor BioCryst Pharmaceuticals
Conditions Hereditary Angioedema, Pediatric
Enrollment 29 participants
Start Date 2022-10-25
Primary Completion 2024-09-11 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-02-25