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Letermovir in Heart Transplant Recipients


Title Evaluation of the tolerability and clinical effectiveness of letermovir in heart transplant recipients
Therapeutic Area Cytomegalovirus Infection
Principal Investigator David R. Snydman, MD
Min Age 18 Years
Max Age 75 Years
Gender All
Contact David R. Snydman, MD
617-636-5788
dsnydman@tuftsmedicalcenter.org

Overview

Open label trial of letermovir prophylaxis for those heart transplant recipients at risk of cytomegalovirus infection and disease

Study Details

Inclusion Criteria

  • Heart transplant at risk for CMV infection or disease
  • Written informed consent
  • Not enrolled in another clinical trial

Exclusion Criteria

  • Dual heart and kidney transplant
  • Creatinine clearance < 10 cc
  • Prior transplant

Study Requirements

This is an open label trial to assess the tolerability and clinical effectiveness of letermovir in preventing CMV disease and infection in heart transplant recipients. Patients who consent will receive letermovir instead of the usual cmv prophylaxis of ganciclovir or valganciclovir. There are no extra visits or study related activites except for one extra blood draw. Patients will be followed as they are per usual care. The only other activity will be to maintain pill counts for adherence and to take calls to assure compliance with the therapy and assess tolerability.