Trials / Completed
CompletedNCT03940586
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
A Phase 2b Open-label, Single-arm Study to Evaluate Pharmacokinetics, Efficacy, Safety and Tolerability of Letermovir in Pediatric Participants From Birth to Less Than 18 Years of Age at Risk of Developing CMV Infection and/or Disease Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-08-08
- Primary completion
- 2023-01-04
- Completion
- 2023-08-25
- First posted
- 2019-05-07
- Last updated
- 2024-08-22
- Results posted
- 2024-01-30
Locations
40 sites across 11 countries: United States, Australia, Colombia, France, Germany, Israel, Japan, Mexico, Poland, Spain, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03940586. Inclusion in this directory is not an endorsement.