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)

Part of paid clinical trials in San Francisco, California.

Sponsor: Tenaya Therapeutics
Study ID: NCT06311708
Status: Recruiting

Conditions

Arrhythmogenic Right Ventricular Cardiomyopathy

Eligibility Criteria

Sex: ALL
Age: 14 Years - 65 Years
Healthy Volunteers: Not accepted

Study Details

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 Dates

Start date: Jan 31, 2023
Status verified: Oct 2024
Primary completion: Mar 29, 2030
Completion: Jul 11, 2030

Study Design

Enrollment: 200 participants (estimated)

Arms

Arm: Retrospective and Prospective
Patients who meet the eligibility criteria are observed and data collected both prospectively and retrospectively.

Primary Outcome Measure

Investigate the seroprevalence of pre-existing antibodies to AAV9 in patients with PKP2-associated ARVC [ Time Frame: 5 years ]

Central Contacts

Matthew Pollman, MD
650-209-8092
[email protected]
Niharika Kamat, MS
[email protected]

Locations (8)

Facility	City	State	ZIP	Site coordinators
University of California San Francisco	San Francisco	California	94143	Vasanth Vedantham, MD, PhD
University of Colorado, Denver	Aurora	Colorado	80045	Matthew Taylor, MD, PhD
John Hopkins University School of Medicine	Baltimore	Maryland	21287	Hugh G Calkins, MD
Brigham and Women's Hospital	Boston	Massachusetts	02115	Neal Lakdawala, MD
Mayo Clinic	Rochester	Minnesota	55905	John Giudicessi, MD PhD
New York University	New York	New York	10016	Larry Chinitz, MD
Cleveland Clinic	Cleveland	Ohio	44195	Wai Hong Wilson Tang, MD
Medical University of South Carolina	Charleston	South Carolina	29425	Daniel Judge, MD

Find similar trials in San Francisco, CA

By research site

University of California San Francisco· San Francisco, CA University of Colorado, Denver· Aurora, CO John Hopkins University School of Medicine· Baltimore, MD Brigham and Women's Hospital· Boston, MA Mayo Clinic· Rochester, MN New York University· New York, NY

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