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

Study acronym: APeX-A
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Study sites: 13 to 16
    v8
  2. Study sites: 11 to 13v7
  3. Primary and study completion dates: Aug 2026 to Aug 2031
    • Enrollment target: 110 to 139
    • Eligibility criteria expanded, about 12 words
    • Study description expanded, about 63 words
    v6
  4. 3 versions Re-verified since May 17, 2023, no change to tracked fieldsv3-v5
  5. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 11
    • Start date changed from estimate of Jun 2021 to Jul 23, 2021
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.
Trial Details
NCT Number NCT04933721
Lead Sponsor BioCryst Pharmaceuticals
Conditions
(from sponsor)		 Hereditary Angioedema, HAE
Related terms Angioedemas, Hereditary
Enrollment 139 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov