This study tests the safety of letermovir, a medicine for newborns with symptomatic congenital Cytomegalovirus (CMV) disease. CMV is a virus that can cause serious health issues in babies, like hearing problems. The study involves taking blood samples to see how the body handles letermovir and checking for any side effects.
Phase 1 means it's an early study to test safety and dosage. Single-arm and open-label mean everyone knows what treatment is being given, and there is no comparison group. The study will include two groups of babies, with the first group receiving a single dose of letermovir to check initial results. If results are good, babies will start a 14-day treatment. Safety checks include blood tests on specific days and additional medicine called valganciclovir, which is already a standard treatment.
- Study lasts about 6 months with several doctor visits.
- Regular blood tests to monitor safety and medicine effects.
- Free treatment and follow-ups are provided for participating babies.