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Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)

NCT03940586 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-08-22

Study results available
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Summary

The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to \<18 years of age (adolescents); Age Group 2: From 2 to \<12 years of age (children); and Age Group 3: From birth to \<2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (\~100 days) post-transplant, with doses based on body weight and age.

Conditions

  • Cytomegalovirus (CMV) Infection

Interventions

DRUG

Letermovir oral granules

Granules administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.

DRUG

Letermovir tablet

Tablet administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.

DRUG

Letermovir intravenous

Letermovir administered intravenously based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-08
Primary Completion
2023-01-04
Completion
2023-08-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Colombia
  • France
  • Germany
  • Israel
  • Japan
  • Mexico
  • Poland
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03940586 on ClinicalTrials.gov