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A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus
NCT06118515 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase 1 single-arm open-label study of letermovir in neonates with symptomatic congenital Cytomegalovirus (CMV) disease. There will be two groups enrolled. Group 1 will be comprised of 4 subjects. Following documentation study inclusion and signing of informed consent, Group 1 subjects will receive one dose of oral letermovir (Study Day 0), using the dose bands. A full pharmacokinetics (PK) profile will then be obtained over the next 24 hours, and blood specimens will be shipped immediately to the University of Alabama at Birmingham (UAB) Pharmacokinetic Lab and processed in real time. Within = 7 days, pharmacokinetics (PK) results will be conveyed to the study site. If the Area Under the Curve (AUC24) is =100,000 ngxhr/mL (see footnote a in Table 1), the subject will initiate a 14-day course of once-daily oral letermovir at the same dose as utilized on Dose Finding Day. This duration of letermovir therapy was selected based upon our earlier observation in this population that patients with symptomatic congenital Cytomegalovirus (CMV) disease who achieve viral suppression to =2.5 log by day 14 of valganciclovir therapy and then maintain it over the next 4 months are statistically more likely to have improved hearing across the first two years of life (22). If the observed letermovir exposure of the subject is \> 100,000 ngxhr/mL, the once-daily oral letermovir dose that will be used will be adjusted down in 2.5 mg increments. Oral valganciclovir (16 mg/kg/dose BID) will begin within the first month of life, as standard of care; initiation of valganciclovir can be concomitant with or prior to initiation of the 14-day course of letermovir (but will not start before obtaining the pharmacokinetics (PK) specimens following the single dose of letermovir on the Dose Finding Day). This is similar to the intensification approach that has been evaluated in the management of patients infected with human immunodeficiency virus (23-25). The day that the 14-day course o
Conditions Studied
Interventions
- DRUG Letermovir
Study Locations (10)
Alabama
- Children's of Alabama Child Health Research Unit (CHRU) — Birmingham
District of Columbia
- Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease — Washington D.C.
Georgia
- Emory University School of Medicine — Atlanta
Kentucky
- University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases — Louisville
Louisiana
- Louisiana State University Health Shreveport - Infectious Diseases — Shreveport
Minnesota
- University of Minnesota - Pediatric Infectious Disease — Minneapolis
New York
- SUNY Upstate Medical University Hospital - Pediatrics — Syracuse
Ohio
- Nationwide Children's Hosp.-Neonatology-Ctr. for Perinatal Rsrch. — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-02-19 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06118515
The ClinicalTrials.gov registry entry for NCT06118515 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Congenital Cytomegalovirus Infection appearing as the primary indexed condition, and to 1 intervention — of which Letermovir is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06118515 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Alabama, District of Columbia, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06118515 about?
NCT06118515 is a clinical study titled "A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus". This is a Phase 1 single-arm open-label study of letermovir in neonates with symptomatic congenital Cytomegalovirus (CMV) disease. There will be two groups enrolled. Group 1 will be comprised of 4 subjects. Following documentation study inclusion and signing of informed consent, Group 1 subjects wil...
What is the current status of trial NCT06118515?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-02-19. Estimated completion is 2026-08-31.
What conditions does trial NCT06118515 study?
This clinical trial studies the following conditions: Congenital Cytomegalovirus Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06118515?
The interventions under investigation include: Letermovir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06118515?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06118515 being conducted?
This trial has 10 study locations across Alabama, District of Columbia, Georgia, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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