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A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus

Testing Letermovir safety in infants with congenital cytomegalovirus symptoms.

Recruiting
90 years and younger
All
Phase 1
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study looks at the safety of a medicine called letermovir in babies with a viral infection called congenital Cytomegalovirus (CMV). CMV is a virus that can cause problems in newborns. Letermovir is given to the babies in the form of a liquid they swallow. The study has two groups of babies. The first group gets one dose of letermovir, and doctors check how much medicine is in the blood over 24 hours. If it's safe, the baby gets letermovir every day for 14 days. The second group may start letermovir at the same time as another medicine called valganciclovir. Valganciclovir is a different medicine already used to treat CMV, and it's given for 6 months. This study helps doctors see how much letermovir is safe for babies. They will also track the virus in the baby's body and see if the virus comes back after stopping the medicine. Doctors take blood samples to check safety and how well the medicine works. Parents should know the study lasts several months, involves many doctor visits, and checks blood samples regularly.

  • Study lasts for several months with regular doctor visits
  • Involves blood samples to monitor safety and drug levels
  • Letermovir is an additional treatment to the standard valganciclovir therapy
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Study details
    Congenital Cytomegalovirus Infection

NCT06118515

National Institute of Allergy and Infectious Diseases (NIAID)

16 March 2025

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