Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

Recruiting Phase 3 Interventional Study
Pregnant Women CMV Infected Fetuses
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
46 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
The investigators' hypothesis is that maternal treatment with Letermovir will inhibit fetal CMV replication better than Valaciclovir in infected fetuses and lead to a higher proportion of negative CMV PCR at birth in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP). The main objective is to demonstrate that Letermovir administered to wom…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Pregnant woman ≥ 18 years old, * CMV infection in the 1st trimester * with an infected fetus at 15 -28 weeks (positive CMV PCR in the amniotic fluid) With a fetus presenting without any severe cerebral ultrasound feature (ventriculomegaly ≥15 mm, hydrocephalus, periventricular…
Contacts

Yves VILLE, MD, PhD

+33 1 71 19 63 32

ville.yves@gmail.com

CONTACT

Aminata TRAORE

+33 1 48 19 27 34

aminata.traore6@aphp.fr

CONTACT