Seroprevalence Study of Pre-existing Immunity for Adenovirus-associated Virus Vector in MYBPC3-associated Hypertrophic Cardiomyopathy

Overview

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.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Giudicessi, M.D., Ph.D.

Open for enrollment

Contact information:

Carla Haglund-Turnquist

(507) 284-8900

HaglundTurnquist.Carla@mayo.edu

More information

Publications

Publications are currently not available