Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
Public ClinicalTrials.gov record NCT03940586. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03940586
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 8, 2019 (Actual)
- Primary completion
- Jan 4, 2023 (Actual)
- Completion
- Aug 25, 2023 (Actual)
- Last update posted
- Aug 22, 2024
2019 – 2023
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center ( Site 0251) | Duarte | California | 91010 | — |
| Children's Hospital of Orange County ( Site 0241) | Orange | California | 92868 | — |
| UCSF Benioff Children's Hospital San Francisco ( Site 0245) | San Francisco | California | 94158 | — |
| University Of Chicago School Of Medicine ( Site 0253) | Chicago | Illinois | 60637 | — |
| Boston Children's Hospital ( Site 0243) | Boston | Massachusetts | 02115-5737 | — |
| Memorial Sloan Kettering Cancer Center ( Site 0254) | New York | New York | 10065 | — |
| Duke University Health System ( Site 0252) | Durham | North Carolina | 27705 | — |
| Cincinnati Children's Hospital Medical Center ( Site 0244) | Cincinnati | Ohio | 45229 | — |
| Children's Hospital of Pittsburgh of UPMC ( Site 0258) | Pittsburgh | Pennsylvania | 15224 | — |
| Children's Medical Center ( Site 0257) | Dallas | Texas | 75235 | — |
| Seattle Childrens Hospital ( Site 0248) | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03940586, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 22, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03940586 live on ClinicalTrials.gov.