Prenatal Treatment of Congenital Cytomegalovirus Infection with Letermovir Versus Valaciclovir

PHASE3RecruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

October 20, 2023

Primary Completion Date

August 31, 2029

Study Completion Date

August 31, 2029

Conditions
Pregnant WomenCMV Infected Fetuses
Interventions
DRUG

Letermovir

Maternal daily administration of 240 milligrams of letermovir (1x240 mg-tablets) up-until delivery or TOP Placebo of Valaciclovir ; daily administration of 8 grams of valaciclovir (2 g (4 x500 mg-tablets) every 6 hours) up-until delivery or TOP

DRUG

Valacyclovir

Maternal daily administration of 8 grams of valaciclovir (2 g (4 x500 mg-tablets) every 6 hours) up-until delivery or TOP Placebo of letermovir : (1x240 mg-tablets) up-until delivery or TOP

Trial Locations (1)

75015

RECRUITING

Hopital Necker - Enfants malades, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER