Phase 4 N=236 Other

Letermovir Use in Heart Transplant Recipients

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

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View on ClinicalTrials.gov: NCT04904614 ↗

Enrolled (actual)

236

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Proportion of Patients With Neutropenia Compared to Historical Controls — 0; 30 Participants — p=0.02

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Letermovir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tufts Medical Center
Primary completion: Jan 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients With Neutropenia Compared to Historical Controls	0; 30	0.02 sig
SECONDARY Rate of CMV Infection in Letermovir Recipients Compared to Historical Controls	11; 50	0.13
SECONDARY Rate of Opportunistic Infections in Letermovir Arm Compared to Historical Controls	3; 25	0.6
SECONDARY Tolerability and Compliance of Letermovir	—	—
SECONDARY Use of Granulocyte Colony Stimulation Factor (GCSF) in Letermovir Recipients Compared to Historical Controls	9; 58	0.97
SECONDARY Measure of CMV Specific T Cell Immunity in Letermovir Recipients	20; 4; 5	—

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.

Eligibility Criteria

Inclusion Criteria

Adults between 18-70 will be eligible for participation
Written informed consent and able to participate with follow up
Heart transplant recipients who are not Cytomegalovirus (CMV) donor negative and CMV recipient negative (CMV D-/R-)
Not enrolled in competing clinical trials

Exclusion Criteria

Dual heart and kidney transplant recipients
Patients who do not survive 72 hours post transplant
HIV infection
Patients with creatinine clearance less than 10 ml per min at time of enrollment
Hypersensitivity to letermovir
On continuous veno-venous hemofiltration or renal dialysis at the time of enrollment
Received a previous solid organ transplant or stem cell transplant.
Has Child Pugh Class C severe hepatic insufficiency at screening.
Has both moderate hepatic insufficiency AND moderate to severe renal insufficiency at screening.

Note: Moderate hepatic insufficiency is defined as Child Pugh Class B; moderate to severe renal insufficiency is defined as Creatine Clearance 2.5 × ULN ALT >5 × ULN AST >5 × ULN

ALT = alanine aminotransferase; AST = aspartate aminotransferase; CMV = cytomegalovirus; IgG = immunoglobulin G; ULN = upper limit of normal

Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5× half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing on this study. Participants previously treated with an investigational monoclonal antibody will be eligible to participate after a 150-day washout period.

Note: Investigational regimens involving combinations of approved agents are not permitted. Other non-interventional or other observational studies are allowed.

Has previously participated in this study or any other study involving letermovir.
Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04904614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.