Researchers are looking for a way to prevent cytomegalovirus (CMV) in children and adolescents who receive a kidney transplant (KT) and weigh less than 40 kilograms (88.2 pounds). The goals of the study are to:
* Learn what happens to letermovir in the body over time * Learn about the safety of letermovir and if participants tolerate it
Is a recipient of a primary or secondary allograft kidney
Is at least 4 weeks posttransplant and not more than 52 weeks posttransplant at the time of enrollment (Day 1) and is being managed per local standard of care
Has stable kidney function posttransplant
Has undetectable CMV deoxyribonucleic acid (DNA) from a plasma or whole blood sample collected within 14 days prior to enrollment
Has CMV disease or suspected CMV disease between screening and enrollment
Is on dialysis or plasmapheresis at the time of enrollment
Has evidence of CMV viremia at any time from screening until the time of enrollment
Has Child-Pugh B or C hepatic insufficiency within 14 days before enrollment
Single group
Letermovir
DrugAdministered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.
Area Under the Curve From Time 0 to 24 Hours (AUC0-24)
Blood samples will be collected at multiple time points to estimate AUC0-24
Percentage of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported.
Percentage of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study treatment due to an AE is reported.
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