Status:
RECRUITING
A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Congenital Cytomegalovirus Infection
Eligibility:
All Genders
Up to 90 years
Phase:
PHASE1
Brief 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 sub...
Detailed Description
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 sub...
Eligibility Criteria
Inclusion
- Signed informed consent from parent(s) or legal guardian(s)
- Cytomegalovirus (CMV) confirmation by culture, shell vial, or Polymerase Chain Reaction (PCR) tests from a specimen obtained at \</= 30 days of life from saliva, blood, or urine
- Symptomatic congenital CMV disease\*
- Age at study enrollment:
- \</= 83 days for Group 1 subjects\*\*
- \</= 90 days for Group 2 subjects
- Weight at study enrollment 2.6 kg to \< 8.0 kg
- Gestational age \>/= 32 weeks at birth
- Intention by patient's physician to clinically treat infant with oral valganciclovir for 6 months for symptomatic congenital CMV disease
- Manifested by one or more of the following: thrombocytopenia; petechiae; hepatomegaly; splenomegaly; intrauterine growth restriction; hepatitis; or Central Nervous System (CNS) involvement such as microcephaly, radiographic abnormalities indicative of CMV CNS disease, abnormal cerebrospinal fluid (CSF) indices for age, chorioretinitis, hearing deficits as detected by formal brainstem evoked response, and/or positive CMV Polymerase Chain Reaction (PCR) from CSF \*\*Group 1 subjects must enroll and receive the Dose Finding Day dose of letermovir on or before 83 days of life so that oral valganciclovir can be started prior to 12 weeks 6 days (which is 90 days) of life, as is standard of care. For this study, the date of birth is counted as day of life 0
Exclusion
- Imminent demise
- Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry)
- Current receipt of other investigational drugs
- Grade 3 or 4 alanine aminotransferase (ALT) utilizing Division of AIDS (DAIDS) Toxicity Table
- Grade 3 or 4 total bilirubin utilizing DAIDS Toxicity Table
- Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
- Anticipated concomitant administration of carbamazepine (Tegretol), nafcillin, phenobarbital, or phenytoin (Dilantin) during the period of study drug administration
Key Trial Info
Start Date :
February 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06118515
Start Date
February 19 2025
End Date
August 31 2026
Last Update
January 5 2026
Active Locations (10)
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1
Children's of Alabama Child Health Research Unit (CHRU)
Birmingham, Alabama, United States, 35233-0011
2
Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease
Washington D.C., District of Columbia, United States, 20010-2916
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322-1014
4
University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases
Louisville, Kentucky, United States, 40202