Actively Recruiting
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)
Led by Tenaya Therapeutics · Updated on 2024-11-01
200
Participants Needed
21
Research Sites
388 weeks
Total Duration
On this page
Sponsors
T
Tenaya Therapeutics
Lead Sponsor
U
University of California, San Francisco
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 14 to 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 implantable cardioverter defibrillator (ICD)
You will not qualify if you...
- 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
- Concurrent participation in another interventional clinical trial unless approved by the Sponsor
- History of cardiac transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
University of Colorado, Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
3
John Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
New York University
New York, New York, United States, 10016
Actively Recruiting
7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
9
Hopital Louis Pradel
Bron, France
Actively Recruiting
10
Nantes University Hospital
Nantes, France, 44000
Actively Recruiting
11
Pitié-Salpêtrière Hospital
Paris, France, 75013
Actively Recruiting
12
Hôpital Haut-Lévêque
Pessac, France, 33604
Actively Recruiting
13
University Hospital Muenster
Münster, Germany, 48149
Actively Recruiting
14
Wuerzburg University Hospital
Würzburg, Germany, 97080
Actively Recruiting
15
Centro Cardiologico Monzino
Milan, Italy, 20138
Actively Recruiting
16
Istituti Clinici Scientifici Maugeri SpA
Pavia, Italy
Actively Recruiting
17
Skåne University Hospital
Malmö, Sweden, 214 28
Actively Recruiting
18
The Queen Elizabeth Hospital
Glasgow, United Kingdom, G514TF
Actively Recruiting
19
Barts & The London Health NHS Trust
London, United Kingdom, E1 1BB
Actively Recruiting
20
St. George's University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0QT
Actively Recruiting
21
Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom, SW3 6NP
Actively Recruiting
Research Team
M
Matthew Pollman, MD
CONTACT
N
Niharika Kamat, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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