Status:
COMPLETED
Letermovir Use in Heart Transplant Recipients
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Cytomegalovirus Disease
Cytomegalovirus Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 cytomegalovi...
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 catego...
Eligibility Criteria
Inclusion
- 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
- 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 \<50 mL/min, as calculated by the Cockcroft-Gault equation (as above), respectively.
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy.
- Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.
- Is expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.
- Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or put the participant at undue risk, as judged by the investigator, such that it is not in the best interest of the participant to participate in this study.
- Has exclusionary laboratory value at screening, as listed in Table 1. Table 1 Laboratory Exclusion Criteria Laboratory Assessment Exclusionary Value
- Hemoglobin \<8 g/dL Platelets \<25,000 cells/µL Absolute neutrophil count \<1,000 cells/µL Total bilirubin \>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.
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Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04904614
Start Date
January 5 2022
End Date
January 14 2025
Last Update
July 29 2025
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111