Letermovir for Cytomegalovirus (CMV) infection in heart transplant recipients

Inclusion criteria

• {"criterion_text":"- •heart transplant recipient (new)"}
• {"criterion_text":"- •moderate (D+/R+ and D-/R+) or high (D+/R-) risk CMV serostatus"}
• {"criterion_text":"- •signed informed consent for participation in the study"}
• {"criterion_text":"- • age ≥ 18 years"}
• {"criterion_text":"- •not enrolled in competing clinical trials"}

Exclusion criteria

• {"criterion_text":"- •short-term mechanical circulatory support prior HTX"}
• {"criterion_text":"- •known hypersensitivity to letermovir"}
• {"criterion_text":"- •known hypersensitivity to valgancyclovir"}
• {"criterion_text":"- •known hematological disorders (apart from anemia)"}
• {"criterion_text":"- •history of malignancy (< 5 years; except adequately treated basal or squamous cell skin cancer or in situ cervical cancer) or under evaluation for active or suspected malignancy"}
• {"criterion_text":"- •advanced kindey disease (CrCL < 10 ml/min) at enrollment"}
• {"criterion_text":"- •advanced liver disease (Child Pugh Class C)"}
• {"criterion_text":"- •combined moderate kidney (CrCL < 50 ml/min) and liver (Child Pugh Class B) insufficiency at screening"}
• {"criterion_text":"- •concomitant administration with pimozide"}
• {"criterion_text":"- •concomitant administration with ergot alkaloids"}
• {"criterion_text":"- •concomitant administration with St. John’s wort (Hypericum perforatum)"}
• {"criterion_text":"- •multi-organ transplantation"}
• {"criterion_text":"- •concomitant administration of cyclosporine"}
• {"criterion_text":"- •concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated"}
• {"criterion_text":"- •known hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption"}
• {"criterion_text":"- •combined hepatic and renal impairment"}
• {"criterion_text":"- •HIV infection"}
• {"criterion_text":"- •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"}
• {"criterion_text":"- •Has previously participated in this study or any other study involving letermovir."}
• {"criterion_text":"- •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."}
• {"criterion_text":"- •ongoing CMV infection/disease"}
• {"criterion_text":"- •D-/R- CMV serostatus"}
• {"criterion_text":"- •heart re-transplantation"}
• {"criterion_text":"- •need for intensified immunosuppression protocol (>20% cytolytic alloantibodies prior transplant or perioperative (within 7 days after HTX) allograft rejection > 1R)"}
• {"criterion_text":"- •immunoinduction with ATG"}
• {"criterion_text":"- •pregnancy"}
• {"criterion_text":"- •active participation in another interventional clinical trial"}

Primary endpoints

• {"endpoint_text":"- The rate of early CMV infections/disease during virostatic prophylaxis.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- •The rate of leukopenia during virostatic prophylaxis","definition_or_measurement_approach":""}
• {"endpoint_text":"- •The rate of neutropenia during virostatic prophylaxis","definition_or_measurement_approach":""}
• {"endpoint_text":"- •The rate of late CMV infections/disease between virostatic discontinuation and 6 months thereafter.","definition_or_measurement_approach":""}
• {"endpoint_text":"- •The time-course of the restitution of cell-mediated immunity during virostatic prophylaxis","definition_or_measurement_approach":""}
• {"endpoint_text":"- •The rate of CMV resistance to virostatic therapy.","definition_or_measurement_approach":""}

Slovenia

Earliest CTIS Part Ii Submission Date

28-08-2024

Latest Decision Or Authorization Date

17-09-2024

Processing Time Days

20

Number Of Sites

1

Number Of Participants

90

Primary sponsor

Full Name

University Medical Center Ljubljana

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Slovenia