Purpose

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

Condition

Eligibility

Eligible Ages
Under 17 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Weight-banded letermovir dosing
Participants who are between 4 and 52 weeks post-KT will receive letermovir for 7 consecutive days.
  • Drug: Letermovir
    Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.
    Other names:
    • MK-8228
    • AIC246
    • AIC001
    • PREVYMIS™

Recruiting Locations

UCLA Clinical & Translational Research Center (CTRC) ( Site 0006)
Los Angeles, California 90095
Contact:
Study Coordinator
310-825-5225

Lucile Packard Children's Hospital ( Site 0001)
Palo Alto, California 94304
Contact:
Study Coordinator
408-828-5120

University of California Davis Health ( Site 0023)
Sacramento, California 95817
Contact:
Study Coordinator
916-734-8036

UCSF Medical Center at Mission Bay ( Site 0017)
San Francisco, California 94158
Contact:
Study Coordinator
415-347-1885

Children's Hospital Colorado ( Site 0013)
Aurora, Colorado 80045
Contact:
Study Coordinator
720-777-6263

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004)
Chicago, Illinois 60611
Contact:
Study Coordinator
312-227-2061

University of Michigan ( Site 0014)
Ann Arbor, Michigan 48109
Contact:
Study Coordinator
734-936-6280

Mayo Clinic - Rochester ( Site 0015)
Rochester, Minnesota 55905
Contact:
Study Coordinator
507-254-1714

Morgan Stanley Children's Hospital ( Site 0018)
New York, New York 10032
Contact:
Study Coordinator
212-305-2500

Duke University Medical Center ( Site 0008)
Durham, North Carolina 27710
Contact:
Study Coordinator
919-684-6335

Cincinnati Children's Hospital Medical Center ( Site 0002)
Cincinnati, Ohio 45229
Contact:
Study Coordinator
513-636-7499

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.