NCT06311708 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)
| NCT ID | NCT06311708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tenaya Therapeutics |
| Condition | Arrhythmogenic Right Ventricular Cardiomyopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2030-03-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-01-31 with a primary completion date of 2030-03-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06311708 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 65 Years, studying Arrhythmogenic Right Ventricular Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06311708 currently recruiting?
Yes, NCT06311708 is actively recruiting participants. Contact the research team at mpollman@tenayathera.com for enrollment information.
Where is the NCT06311708 trial being conducted?
This trial is being conducted at San Francisco, United States, Aurora, United States, Baltimore, United States, Boston, United States and 11 additional locations.
Who is sponsoring the NCT06311708 clinical trial?
NCT06311708 is sponsored by Tenaya Therapeutics. The trial plans to enroll 200 participants.