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NCT03940586 · ClinicalTrials.gov registry record · Phase 2
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
A Phase 2 study of Cytomegalovirus (CMV) Infection, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 20
- Study locations
NCT03940586: Completed Phase 2 study of Cytomegalovirus (CMV) Infection, sponsored by Merck Sharp & Dohme.
NCT03940586 is a Phase 2 study of Cytomegalovirus (CMV) Infection that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03940586, a Phase 2 study of Cytomegalovirus (CMV) Infection, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Blood was collected on treatment Day 7 from participants aged 2 - \<18 years in order to determine the AUC0-24 of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \< 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Conditions Studied
Interventions
- DRUG Letermovir oral granules
- DRUG Letermovir tablet
- DRUG Letermovir intravenous
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center ( Site 0251) - Duarte
- Children's Hospital of Orange County ( Site 0241) - Orange
- UCSF Benioff Children's Hospital San Francisco ( Site 0245) - San Francisco
Valle del Cauca Department
- Fundacion Valle del Lili ( Site 0212) - Cali
- Centro Medico Imbanaco de Cali S.A ( Site 0211) - Cali
Illinois
- University Of Chicago School Of Medicine ( Site 0253) - Chicago
Massachusetts
- Boston Children's Hospital ( Site 0243) - Boston
New York
- Memorial Sloan Kettering Cancer Center ( Site 0254) - New York
North Carolina
- Duke University Health System ( Site 0252) - Durham
Ohio
- Cincinnati Children's Hospital Medical Center ( Site 0244) - Cincinnati
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC ( Site 0258) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2019-08-08 |
| Est. Completion | 2023-08-25 |
| Phase | Phase 2 |
What the finished NCT03940586 record still lists
NCT03940586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Cytomegalovirus (CMV) Infection appearing as the primary indexed condition, and to 3 interventions - of which Letermovir oral granules is the first listed.
NCT03940586 names 20 study sites across 17 states, led by California, Valle del Cauca Department, Illinois.
Frequently Asked Questions
What is clinical trial NCT03940586 about?
NCT03940586 is a clinical study titled "Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)". 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 A...
What is the current status of trial NCT03940586?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2019-08-08. Estimated completion is 2023-08-25.
What conditions does trial NCT03940586 study?
This clinical trial studies the following conditions: Cytomegalovirus (CMV) Infection.
What interventions are being tested in trial NCT03940586?
The interventions under investigation include: Letermovir oral granules (DRUG), Letermovir tablet (DRUG), Letermovir intravenous (DRUG).
Who is sponsoring clinical trial NCT03940586?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03940586 being conducted?
This trial has 20 study locations across California, Illinois, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03940586's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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