Seroprevalence Study of Pre-existing Immunity for Adenovirus-associated Virus Vector in MYBPC3-associated Hypertrophic Cardiomyopathy
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-005284
Sponsor Protocol Number: TN-201-0008
About this study
The purpose of this study is to investigate the seroprevalence of pre-existing immunity to adenovirus-associated virus (AAV) in patients with myosin binding protein (MYBPC3)-associated hypertrophic cardiomyopathy (HCM).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Signed informed consent.
- Ages ≥18 to ≤65 years.
- Diagnosed with HCM per American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines (maximal left ventricular wall thickness >13 mm).
- Symptomatic HCM (New York Heart Association [NYHA] Class II-IV).
- Confirmed Pathogenic/Likely Pathogenic MYBPC3 truncating mutation.
Exclusion Criteria:
- Currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy, immunoglobulin therapy, or monoclonal antibody therapy.
- History of clinically significant liver disease, HBV, HCV, HIV, or latent tuberculosis infection.
- Previously dosed with any investigational or approved gene therapy product at any time.
Eligibility last updated 4/17/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available