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Clinical Trials in the USA / NCT06311708
Recruiting Observational

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)

NCT06311708 · tracked via the Priya Life Science USA tracker
Sponsor
Tenaya Therapeutics
Phase
Observational
Started
2023-01-31
Last updated
2024-11-01

Condition(s) studied

Arrhythmogenic Right Ventricular Cardiomyopathy

Study 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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (21)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06311708 on ClinicalTrials.gov ↗ ← All trials in the USA