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NCT07199465
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Conditions: Cytomegalovirus Prophylaxis
Sex: All
Ages: N/A – 17 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 40
Sponsor: Merck Sharp & Dohme LLC
Location: University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019) Birmingham Alabama
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
Eligibility Criteria
Inclusion Criteria:
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 \
Source: ClinicalTrials.gov (NCT07199465). StuddyBuddy aggregates publicly available trial information.