MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Ad… (NCT04129398) | Clinical Trial Compass
CompletedPhase 3
MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)
Japan22 participantsStarted 2019-12-27
Plain-language summary
This study aims to evaluate the safety, efficacy and pharmacokinetics (PK) of Letermovir (LET) administered as prevention of cytomegalovirus (CMV) infection and disease in adult Japanese kidney transplant recipients.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Meets recipient and/or donor CMV Immunoglobulin G (IgG) serostatus.
* Anticipates receiving a primary or secondary allograft kidney at the time of screening and have received a primary or secondary allograft kidney at the time of allocation.
* Is within 0 (i.e., day of transplantation) to 7 days (inclusive) post-kidney transplant at the time of allocation.
* Is a Japanese male or female from 18 years to any years of age inclusive, at the time of signing the informed consent.
* Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP); but if a WOCBP, she is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse, and must have a negative highly sensitive pregnancy test within 72 hours before the first dose of study intervention.
Exclusion Criteria:
* Has received a previous solid organ transplant or hematopoietic stem cell transplant (HSCT).
* Is a multi-organ transplant recipient (e.g., kidney-pancreas).
* Has a history of CMV disease or suspected CMV disease within 6 months prior to allocation.
* Has positive results on CMV assay and/or CMV antigen test at any time between the completion of the transplant surgery and time of allocation.
* Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
* Is on dialysis (for the purposes of this protocol dialysis includes hemofiltration) or plasmapheresis at the time of allocation.
* Has Child-Pugh Class…
What they're measuring
1
Percentage of Participants With Adverse Events (AEs)
Timeframe: Up to week 52 post-transplant
2
Percentage of Participants Who Discontinued From Study Drug Due to an AE