A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms
Merck Sharp & Dohme LLC
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
- Age range
- Up to 17 years
- Sex
- All
- Healthy volunteers
- No
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 vi…