Letermovir Use in Heart Transplant Recipients

NCT04904614 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-07-29

Study results available
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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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04904614 on ClinicalTrials.gov