A Pilot Trial of Letermovir for Secondary Prophylaxis to Prevent Recurrent Cytomegalovirus Disease in Solid Organ Transplant Recipients

What this Trial Is About

Researchers are studying the use of Letermovir as a secondary preventive treatment for cytomegalovirus (CMV) infection and disease in adults who have received solid organ transplants, such as heart, kidney, or liver transplants. This open-label Phase 4 trial evaluates the tolerability and clinical effectiveness of Letermovir in preventing the recurrence of CMV after initial treatment has been completed. The study focuses on transplant recipients who have been treated for CMV infection or disease and are considered by their clinicians to need secondary prophylaxis. Participants will receive Letermovir at a dose of 480 mg taken orally once daily for 60 days. This is a single-arm study where all participants receive the same treatment without a comparison group. The study includes collecting CMV-specific T cell assays at the start and end of the prophylaxis period to monitor immune response. After completing the 60-day treatment, participants will be followed for an additional four months to observe whether CMV infection or disease recurs. During the study, participants will undergo regular assessments including evaluations of CMV relapse rates, opportunistic infections, adverse events related to Letermovir, neutropenia, organ rejection, and T cell function, all measured up to six months after starting treatment. Researchers will monitor participants closely for safety and treatment effects throughout this time. The total involvement period includes the 60-day prophylaxis phase followed by a four-month follow-up, making the full participation roughly six months.

Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients