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Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE

Study acronym: CHAPTER-4
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 6 → 8 primary endpoints
See other at-risk trials from Pharvaris Netherlands B.V.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Trial status changed: Recruiting → Enrolling by Invitation
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 12 of 12 entries
    • Site details revised at 67 of 67 sites
    • Study description shortened, about 1 word
  2. Trial sites expanded: 62 → 67 locationsv12
  3. Trial sites expanded: 24 → 62 locationsv11
  4. Enrollment target: 130 to 170
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 11 to 12
    v10
  5. Study sites: 22 to 24v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 17 to 22v8
  2. Study sites: 15 to 17v7
  3. Study sites: 10 to 15v6
  4. Study sites: 9 to 10v5
  5. Study sites: 3 to 9v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v3
  7. Start date: Dec 2024 to Feb 1, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema
Trial Details
NCT Number NCT06679881
Lead Sponsor Pharvaris Netherlands B.V.
Conditions
(from sponsor)		 Hereditary Angioedema (HAE)
Related terms Angioedemas, Hereditary
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov