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A Phase 1, Dose Escalation Trial of RP-A601 in Subjects With PKP2 Variant-Mediated Arrhythmogenic Cardiomyopathy (PKP2-ACM)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Sep 2025 to Sep 2028
    • Study completion date: Sep 2026 to Sep 2029
    • Site details revised at 1 of 3 sites
    v5
  2. Primary endpoints: 3 to 1
    • Study sites: 2 to 3
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 2 to 3
    v4
  3. Site details revised at 1 of 2 sitesv3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: May 2025 to Sep 2025
    • Study completion date: May 2026 to Sep 2026
    • Start date changed from estimate of Jun 2023 to Aug 29, 2023
    • Site details revised at 2 of 2 sites
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 1 dose escalation trial will assess the safety and preliminary efficacy of a single dose intravenous infusion of RP-A601 in high-risk adult patients with PKP2-ACM.
Trial Details
NCT Number NCT05885412
Lead Sponsor Rocket Pharmaceuticals Inc.
Conditions
(from sponsor)		 PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM)
Related terms Arrhythmogenic Right Ventricular Dysplasia, Death, Sudden, Cardiac, Heart Arrest
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov