CompletedPhase 4

Letermovir Use in Heart Transplant Recipients

United States32 participantsStarted 2022-01-05

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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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.

What they're measuring

Proportion of Patients With Neutropenia Compared to Historical Controls

Timeframe: 12 months

Trial details

NCT IDNCT04904614

SponsorTufts Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-14

Results submitted2025-06-24

View on ClinicalTrials.gov More Cytomegalovirus Disease trials