NCT04904614

Letermovir Use in Heart Transplant Recipients

Evaluation of the Tolerability and Clinical Effectiveness of Letermovir in Heart Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open label trial in which letermovir will be given as prophylaxis for the prevention of cytomegalovirus (CMV) infection and disease to all heart transplants who are at risk for cytomegalovirus. The study will compare a 30 patient prospective cohort to a retrospective cohort of 374 heart transplant recipients for the rates of neutropenia. In addition, the tolerability of letermovir will be assessed in this population.

Detailed description

This open label trial will follow 30 heart transplant recipients at Tufts Medical Center who will receive letermovir in a dose of 480 mg daily for either 3 or 6 months depending on the CMV risk category, and who will be followed for one year. Comparison will be made to a cohort of heart transplant recipients as historical controls in a recently presented study (Chow, J, et al ISHLT 2021). Standard follow up will be provided as if the patients were receiving valganciclovir prophylaxis. Post prophylaxis T cell immunity to all subjects enrolled will be tested. Clinical outcomes are detailed below.

Conditions

• Cytomegalovirus Disease
• Cytomegalovirus Infections
• Heart Transplant Infection
• Antiviral Toxicity
• Neutropenia

Interventions

Type	Name	Description
DRUG	Letermovir	Open label trial of the licensed drug, letermovir, in a population of heart transplant recipients for which it is not yet licensed

Timeline

• Start date: 2022-01-05
• Primary completion: 2025-01-14
• Completion: 2025-01-14
• First posted: 2021-05-27
• Last updated: 2025-07-29
• Results posted: 2025-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study