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Berotralstat Treatment in Children With Hereditary Angioedema

Study acronym: APeX-P
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Results first posted: Feb 25, 2026
    • Secondary endpoints: details revised at 1 of 12 entries
    v11
  2. Primary endpoints: 3 to 6v10 Show 5 more changesShow less
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: 2 to 12
    • Study description expanded, about 26 words
    • Site details revised at 1 of 15 sites
    • Study arms: 1 to 4
  3. Re-verified, no change to tracked fieldsv9
  4. Primary completion date changed from estimate of Jul 2025 to Sep 11, 2024
    • Study completion date: Jul 2027 to Feb 2027
    v8
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 29
    • Site details revised at 15 of 15 sites
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Enrollment target: 20 to 30
    • Secondary endpoints revised (2)
    • Site details revised at 3 of 15 sites
    v6
  2. Study sites revised (15)v5
  3. Site details revised at 3 of 15 sitesv4
  4. Start date changed from estimate of Oct 2022 to Oct 25, 2022
    • Site details revised at 3 of 15 sites
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2022 to Oct 2022
    • Study sites: 16 to 15
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05453968
Lead Sponsor BioCryst Pharmaceuticals
Conditions
(from sponsor)		 Hereditary Angioedema, Pediatric
Related terms Angioedemas, Hereditary
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov