IRB Study Number 22-709
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
This is a prospective, noninterventional, seroprevalence study using a single, blood-based laboratory test study to assess the pre-existing immunity to adenovirus-associated virus (AAV) in a population of patients with myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). Mutations in MYBPC3 are the most common cause of familial HCM. There is only 1 study visit which consists of a single blood draw.
Inclusion Criteria
1) Ages 18 to 65 years
2) Diagnosed with HCM
3) Confirmed MYBPC3 mutation
Exclusion Criteria
1) Currently receiving systemic immunosuppressive therapy, chemotherapy, or monoclonal antibody therapy.
2) History of clinically significant liver disease, HBV, HCV, HIV, or latent tuberculosis infection.
3) Previously dosed with any investigational or approved gene therapy product at any time.
