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Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Study acronym: RIDGE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study Identification, Study Status, Oversight, Contacts/Locationsv7
  2. Site details revised at 1 of 21 sitesv6
  3. Study sites: 22 to 21
    • Collaborators: 22 to 21
    v5
  4. Site details revised at 2 of 22 sitesv4
  5. Study sites: 23 to 22
    • Collaborators: 23 to 22
    v3
  6. Study sites: 14 to 23
    • Collaborators: 14 to 23
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.
Trial Details
NCT Number NCT06311708
Lead Sponsor Tenaya Therapeutics
Collaborators: University of California, San Francisco, Brigham and Women's Hospital, New York University, University of Colorado, Denver, Johns Hopkins University, The Cleveland Clinic, Mayo Clinic, Medical University of South Carolina, Hopital Louis Pradel, Istituti Clinici Scientifici Maugeri SpA, The Queen Elizabeth Hospital, St George's University Hospitals NHS Foundation Trust, Royal Brompton & Harefield NHS Foundation Trust, Barts & The London NHS Trust, Skane University Hospital, Centro Cardiologico Monzino, Hôpital Haut-Lévêque, Nantes University Hospital, Pitié-Salpêtrière Hospital, Wuerzburg University Hospital, University Hospital Muenster
Conditions
(from sponsor)		 Arrhythmogenic Right Ventricular Cardiomyopathy
Related terms Arrhythmogenic Right Ventricular Dysplasia, Heart Failure
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov