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NCT06311708 · ClinicalTrials.gov registry record
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)
A clinical trial of Arrhythmogenic Right Ventricular Cardiomyopathy, sponsored by Tenaya Therapeutics.
- Recruiting
- Registry status
- 200
- Enrollment target
- 20
- Study locations
NCT06311708: Recruiting study of Arrhythmogenic Right Ventricular Cardiomyopathy, sponsored by Tenaya Therapeutics.
NCT06311708 is a study of Arrhythmogenic Right Ventricular Cardiomyopathy that is actively recruiting participants, run by Tenaya Therapeutics. The registered enrollment target is 200 participants, below the 334-participant average among 4 other Arrhythmogenic Right Ventricular Cardiomyopathy trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06311708, a study of Arrhythmogenic Right Ventricular Cardiomyopathy, is actively recruiting participants, sponsored by Tenaya Therapeutics.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Study Locations (20)
Other
- Hopital Louis Pradel - Bron
- Nantes University Hospital - Nantes
- Pitié-Salpêtrière Hospital - Paris
- Hôpital Haut-Lévêque - Pessac
- University Hospital Muenster - Münster
- Wuerzburg University Hospital - Würzburg
- Centro Cardiologico Monzino - Milan
- Istituti Clinici Scientifici Maugeri SpA - Pavia
- Skåne University Hospital - Malmo
- The Queen Elizabeth Hospital - Glasgow
- Barts & The London Health NHS Trust - London
- St. George's University Hospitals NHS Foundation Trust - London
California
- University of California San Francisco - San Francisco
Colorado
- University of Colorado, Denver - Aurora
Maryland
- John Hopkins University School of Medicine - Baltimore
Massachusetts
- Brigham and Women's Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
New York
- New York University - New York
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2030-07-11 |
What NCT06311708 shows while recruiting
NCT06311708 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 334-participant average among 4 other Arrhythmogenic Right Ventricular Cardiomyopathy trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Arrhythmogenic Right Ventricular Cardiomyopathy appearing as the primary indexed condition, and to 0 interventions.
NCT06311708 names 20 study sites across 9 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06311708 about?
NCT06311708 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT06311708?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2023-01-31. Estimated completion is 2030-07-11.
What conditions does trial NCT06311708 study?
This clinical trial studies the following conditions: Arrhythmogenic Right Ventricular Cardiomyopathy.
Who is sponsoring clinical trial NCT06311708?
This trial is sponsored by Tenaya Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06311708 being conducted?
This trial has 20 study locations across California, Colorado, Maryland, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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