A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
- Registration Number
- NCT07199465
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
The main inclusion criteria include but are not limited to the following:
- 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
- Must be able to take (as assessed by the investigator) letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube (oral pellets only)
- Does not have a condition that may interfere with the absorption of oral medication (e.g., vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment (Day 1) until the intensive pharmacokinetics (IPK) sampling is completed
- Weighs ≥2.5 and <40 kg at enrollment (Day 1)
The main exclusion criteria include but are not limited to the following:
- 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
- Is a multi-organ transplant recipient (e.g., kidney-pancreas)
- Has any uncontrolled infection on the day of enrollment
- Requires mechanical ventilation, or is hemodynamically unstable, at the time of enrollment
- Has received or is receiving protocol-specified prohibited medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Weight-banded letermovir dosing Letermovir Participants who are between 4 and 52 weeks post-KT will receive letermovir for 7 consecutive days.
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time 0 to 24 Hours (AUC0-24) Day 7: Predose and at designated timepoints post-dose (up to 24 hours) Blood samples will be collected at multiple time points to estimate AUC0-24
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Experience an Adverse Event (AE) Up to 21 days 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 Up to 7 days 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.