NCT06311708Recruiting
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)
Seroprevalence Study of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Source: ClinicalTrials.gov · Last updated 1 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 8 Mar 2024
- Start date
- 31 Jan 2023
- Primary completion date
- 29 Mar 2030
- Lead sponsor
- Tenaya Therapeutics
- Diseases
- Heart failure
- NCT number
- NCT06311708
What you commit to
- Study type: Observational
- Planned participants: 200
- From 31 Jan 2023 to the primary completion date, 29 Mar 2030
- 21 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy, immunoglobulin therapy or monoclonal antibody therapy
- 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.
Other illness
- History of clinically significant liver disease, hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or tuberculosis infection
- History of cardiac transplant.
Who the study is looking for
- 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
Age in the registry: 14 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University hospital Muenster Coordinator of this site? Confirm its status | Münster | Germany | Recruiting |
| Wuerzburg University Hospital Coordinator of this site? Confirm its status | Würzburg | Germany | Recruiting |
| Hôpital Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Nantes University Hospital Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Pitié Salpêtrière Hospital Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| St. George's University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Barts & The London Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Brompton & Harefield NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Centro Cardiologico Monzino Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituti Clinici Scientifici Maugeri SpA Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Skåne University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Recruiting |
| University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| John Hopkins University School of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| New York University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.