RecruitingArrhythmogenic Right Ventricular Cardiomyopathy
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)
Eligible age
14–65 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Tenaya Therapeutics
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's recruiting
California
San Francisco
Colorado
Aurora
Maryland
Baltimore
Massachusetts
Boston
Minnesota
Rochester
New York
New York
Ohio
Cleveland
South Carolina
Charleston
Source: ClinicalTrials.gov · NCT06311708 · last updated 2024-11-01