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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)
Sponsor: Tenaya Therapeutics
Summary
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.
Official title: Seroprevalence Study of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Key Details
Gender
All
Age Range
14 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2023-01-31
Completion Date
2030-07-11
Last Updated
2024-11-01
Healthy Volunteers
No
Locations (21)
University of California San Francisco
San Francisco, California, United States
University of Colorado, Denver
Aurora, Colorado, United States
John Hopkins University School of Medicine
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
New York University
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Hopital Louis Pradel
Bron, France
Nantes University Hospital
Nantes, France
Pitié-Salpêtrière Hospital
Paris, France
Hôpital Haut-Lévêque
Pessac, France
University Hospital Muenster
Münster, Germany
Wuerzburg University Hospital
Würzburg, Germany
Centro Cardiologico Monzino
Milan, Italy
Istituti Clinici Scientifici Maugeri SpA
Pavia, Italy
Skåne University Hospital
Malmo, Sweden
The Queen Elizabeth Hospital
Glasgow, United Kingdom
Barts & The London Health NHS Trust
London, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom