Overview

Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients

Status:
Recruiting
Trial end date:
2026-08-15
Target enrollment:
Participant gender:
Summary
Open label study to determine tolerability and efficacy of letermovir for CMV prophylaxis in heart and lung transplant recipients and compare it to the efficacy of valganciclovir historical controls. The study hypotheses are: 1. Letermovir prophylaxis will be associated with similar rates of CMV infection as valganciclovir among heart and lung transplant recipients 2. Letermovir will be better tolerated than valganciclovir for CMV prophylaxis in heart and lung transplant recipients, with a higher proportion of days of completed therapy with correct dosing during the planned prophylaxis period 3. Letermovir will have a lower rate of neutropenia than valganciclovir when used for CMV prophylaxis in heart and lung transplant recipients 4. Incorrect renal dosing will occur less frequently with letermovir than with valganciclovir when used for CMV prophylaxis in heart and lung transplant recipients
Phase:
Phase 2
Details
Lead Sponsor:
University of Pennsylvania
Collaborator:
Merck Sharp & Dohme LLC
Treatments:
Letermovir