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)

Recruiting now

Conditions studied: Arrhythmogenic Right Ventricular Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT06311708

Run by

Tenaya Therapeutics

People needed

200

Starts

2023-01-31

Expected to finish

2030-07-11

Last updated by the study team

2024-11-01

Who can join

Age: 14 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 14-65 years, inclusive, at the time of consent
• Pathogenic or likely pathogenic PKP2 gene mutation
• Diagnosed with ARVC and meet 2010 Modified Task Force Criteria for ARVC as affected.
• Functioning ICD

You may not qualify if…

• Currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy, immunoglobulin therapy or monoclonal antibody therapy
• History of clinically significant liver disease, hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or tuberculosis infection
• Previously dosed with any investigational or approved gene therapy product at any time
• Concurrent participation in another interventional clinical trial unless approved by the Sponsor. Participation in a noninterventional study may be allowed at the investigator's discretion.
• History of cardiac transplant.

Where it is running

• University of California San Francisco — San Francisco, California, United States (enrolling)
• University of Colorado, Denver — Aurora, Colorado, United States (enrolling)
• John Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• New York University — New York, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Hopital Louis Pradel — Bron, France (enrolling)
• Nantes University Hospital — Nantes, France (enrolling)
• Pitié-Salpêtrière Hospital — Paris, France (enrolling)
• Hôpital Haut-Lévêque — Pessac, France (enrolling)
• University Hospital Muenster — Münster, Germany (enrolling)
• Wuerzburg University Hospital — Würzburg, Germany (enrolling)
• Centro Cardiologico Monzino — Milan, Italy (enrolling)
• Istituti Clinici Scientifici Maugeri SpA — Pavia, Italy (enrolling)
• Skåne University Hospital — Malmö, Sweden (enrolling)
• The Queen Elizabeth Hospital — Glasgow, United Kingdom (enrolling)
• Barts & The London Health NHS Trust — London, United Kingdom (enrolling)
• St. George's University Hospitals NHS Foundation Trust — London, United Kingdom (enrolling)
• Royal Brompton & Harefield NHS Foundation Trust — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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