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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.
Lucile Packard Children's Hospital ( Site 0001)
Palo Alto, California, United States
RECRUITINGUniversity of Michigan ( Site 0014)
Ann Arbor, Michigan, United States
RECRUITINGMayo Clinic - Rochester ( Site 0015)
Rochester, Minnesota, United States
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
Time frame: Day 7: Predose and at designated timepoints post-dose (up to 24 hours)
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.
Time frame: Up to 21 days
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.
Time frame: Up to 7 days
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Morgan Stanley Children's Hospital ( Site 0018)
New York, New York, United States
RECRUITINGDuke University Medical Center ( Site 0008)
Durham, North Carolina, United States
RECRUITINGCincinnati Children's Hospital Medical Center ( Site 0002)
Cincinnati, Ohio, United States
RECRUITING