drugset / Trial / NCT06066957

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

NCT06066957

NaSingle-groupOpen-labelTreatment

Summary

Open label study to determine tolerability and efficacy of letermovir for CMV prophylaxis in heart and lung transplant recipients. 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

Timeline

Start
2024-04-04
Primary completion
2026-08-15
Completion
2026-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Letermovir Small molecule 240 mg Oral
Subject Letermovir Small molecule 480 mg Oral