Letermovir Use in Heart Transplant Recipients
NCT04904614 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2025-07-29
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.
Conditions
- Cytomegalovirus Disease
- Cytomegalovirus Infections
- Heart Transplant Infection
- Antiviral Toxicity
- Neutropenia
Interventions
- DRUG
-
Letermovir
Open label trial of the licensed drug, letermovir, in a population of heart transplant recipients for which it is not yet licensed
Sponsors & Collaborators
- collaborator INDUSTRY
-
Tufts Medical Center
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-05
- Primary Completion
- 2025-01-14
- Completion
- 2025-01-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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