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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
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
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
Letermovir
Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.
Locations (18)
University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019)
Birmingham, Alabama, United States
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
University of Miami School of Medicine ( Site 0021)
Miami, Florida, 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
M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007)
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester ( Site 0015)
Rochester, Minnesota, United States
Morgan Stanley Children's Hospital ( Site 0018)
New York, New York, United States
Montefiore Einstein Center ( Site 0024)
The Bronx, New York, United States
Levine Children's Hospital ( Site 0022)
Charlotte, North Carolina, United States
Duke University-Pediatrics ( Site 0008)
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center ( Site 0002)
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia (CHOP) ( Site 0003)
Philadelphia, Pennsylvania, United States
Texas Children's Hospital ( Site 0005)
Houston, Texas, United States