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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
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

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University hospital Muenster
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MünsterGermanyRecruiting
Wuerzburg University Hospital
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WürzburgGermanyRecruiting
Hôpital Louis Pradel
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BronFranceRecruiting
Nantes University Hospital
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NantesFranceRecruiting
Pitié Salpêtrière Hospital
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ParisFranceRecruiting
Hopital Haut-Leveque
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PessacFranceRecruiting
The Queen Elizabeth Hospital
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GlasgowUnited KingdomRecruiting
St. George's University Hospitals NHS Foundation Trust
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LondonUnited KingdomRecruiting
Barts & The London Health NHS Trust
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LondonUnited KingdomRecruiting
Royal Brompton & Harefield NHS Foundation Trust
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LondonUnited KingdomRecruiting
Centro Cardiologico Monzino
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MilanItalyRecruiting
Istituti Clinici Scientifici Maugeri SpA
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PaviaItalyRecruiting
Skåne University Hospital
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MalmöSwedenRecruiting
University of Colorado Denver
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AuroraUnited StatesRecruiting
John Hopkins University School of Medicine
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BaltimoreUnited StatesRecruiting
Brigham and Women's Hospital
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BostonUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
New York University
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New YorkUnited StatesRecruiting
Mayo Clinic
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RochesterUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.