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Clinical Trials in the USA / NCT07199465
Recruiting Phase 1

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

NCT07199465 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 1
Started
2026-03-30
Last updated
2026-09-14

Condition(s) studied

Cytomegalovirus Prophylaxis

Investigational drug(s) / intervention(s)

Letermovir

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

Study 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

Sex
ALL
Min age
Max age
17 Years
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 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) Exclusion Criteria: 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

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019) Birmingham Alabama Recruiting
Children's Hospital Los Angeles ( Site 0016) Los Angeles California Recruiting
UCLA Clinical & Translational Research Center (CTRC) ( Site 0006) Los Angeles California Recruiting
Lucile Packard Children's Hospital ( Site 0001) Palo Alto California Recruiting
University of California Davis Health ( Site 0023) Sacramento California Recruiting
UCSF Medical Center at Mission Bay ( Site 0017) San Francisco California Recruiting
Children's Hospital Colorado ( Site 0013) Aurora Colorado Recruiting
University of Miami School of Medicine ( Site 0021) Miami Florida Recruiting
Children's Healthcare of Atlanta-Center for Advanced Pediatrics ( Site 0020) Atlanta Georgia Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004) Chicago Illinois Recruiting
University of Michigan ( Site 0014) Ann Arbor Michigan Recruiting
M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007) Minneapolis Minnesota Recruiting
Mayo Clinic - Rochester ( Site 0015) Rochester Minnesota Recruiting
Morgan Stanley Children's Hospital ( Site 0018) New York New York Recruiting
Montefiore Medical Center ( Site 0024) The Bronx New York Recruiting
Levine Children's Hospital ( Site 0022) Charlotte North Carolina Recruiting
Duke University-Pediatrics ( Site 0008) Durham North Carolina Recruiting
Cincinnati Children's Hospital Medical Center ( Site 0002) Cincinnati Ohio Recruiting
Children's Hospital of Philadelphia (CHOP) ( Site 0003) Philadelphia Pennsylvania Recruiting
Children's Hospital of Pittsburgh - Department of Pediatrics ( Site 0011) Pittsburgh Pennsylvania Recruiting
Texas Children's Hospital ( Site 0005) Houston Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07199465 on ClinicalTrials.gov ↗ ← All trials in the USA