Cytomegalovirus Prophylaxis with Letermovir in Heart Transplant Recipients: A Non-randomized Cohort Pilot Study

Ki vehet részt

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

Ki nem vehet részt

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