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A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 days later Apr 2028 → Jun 2028
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Rocket Pharmaceuticals Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Primary completion pushed from Apr 2028 to Jun 2028
    • Enrollment increased: 14 → 18 participants
    • Study completion pushed from Apr 2032 to Jun 2032
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: 6 to 8
    • Study description expanded, about 19 words
    • Study sites revised (6)
  2. Re-verified, no change to tracked fieldsv5
  3. Trial status: Active, Not Recruiting to Recruitingv4 Show 6 more changesShow less
    • Primary completion date: Sep 2025 to Apr 2028
    • Primary endpoint revised
    • Enrollment target: 12 to 14
    • Study completion date: Sep 2029 to Apr 2032
    • Secondary endpoints revised (6)
    • Site details revised at 6 of 6 sites
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 4 to 6
    v3
  5. Primary endpoint revisedv2 Show 4 more changesShow less
    • Study sites: 2 to 4
    • Eligibility criteria shortened, about 53 words
    • Secondary endpoints: 7 to 6
    • Study title shortened, about 3 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 single arm Phase 2 trial to evaluate the efficacy and safety of RP-A501, a recombinant adeno-associated virus serotype 9 (rAAV9) vector containing the human lysosome-associated membrane protein 2 isoform B (LAMP2B) transgene, in male patients with Danon disease.
Trial Details
NCT Number NCT06092034
Lead Sponsor Rocket Pharmaceuticals Inc.
Conditions
(from sponsor)		 Danon Disease
Related terms Cardiomyopathies, Cardiomyopathy, Hypertrophic, Glycogen Storage Disease Type IIb, Hypertrophy, Left Ventricular, Lysosomal Storage Diseases
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov