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RECRUITING
NCT07199465
PHASE1

A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

Any - 17 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-30

Completion Date

2028-05-19

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Letermovir

Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.

Locations (11)

UCLA Clinical & Translational Research Center (CTRC) ( Site 0006)

Los Angeles, California, United States

Lucile Packard Children's Hospital ( Site 0001)

Palo Alto, California, United States

University of California Davis Health ( Site 0023)

Sacramento, California, United States

UCSF Medical Center at Mission Bay ( Site 0017)

San Francisco, California, United States

Children's Hospital Colorado ( Site 0013)

Aurora, Colorado, United States

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004)

Chicago, Illinois, United States

University of Michigan ( Site 0014)

Ann Arbor, Michigan, United States

Mayo Clinic - Rochester ( Site 0015)

Rochester, Minnesota, United States

Morgan Stanley Children's Hospital ( Site 0018)

New York, New York, United States

Duke University Medical Center ( Site 0008)

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center ( Site 0002)

Cincinnati, Ohio, United States