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

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

  • Cytomegalovirus Prophylaxis

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