NCT05446571 Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir
| NCT ID | NCT05446571 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Pregnant Women |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 46 participants in total. It began in 2023-10-20 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 women carrying a CMV infected fetus following a maternal infection of the first trimester increases the proportion of neonates with a negative CMV PCR in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP) compared to Valaciclovir. In each group , the proportion of asymptomatic neonates and the number and type of long-term sequelae at 2 years will also be assessed and compared.
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 hyperechogenicity, microcephaly\<-3SD, vermian hypoplasia, porencephaly, lissencephaly, corpus callosum dysgenesis, cystic leukomalacia) * affiliation to a social security regime//health insurance * Given consent for the study * Patient must be able and willing to comply with study visits and procedures Exclusion Criteria * Participation to another interventional drug trial (category 1) * Subject protected by law under guardianship or curatorship * Maternal CMV infection after 15 weeks' * Creatinine clearance \<50 ml/mn/1,73m² * Liver insufficiency (Child Pugh grade C), AST, ALT 5 x ULN, bilirubin 2 x ULN. * Woman with known allergy to Letermovir or Valaciclovir * Contraindication for the administration of Letermovir and Valaciclovir listed in the SmPC of Prevymis® and Zelitrex® * Women with hypersensitivity to aciclovir * Concomitant administration of St John's wort * Woman treated by pimozide, ergot alkaloids, dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatin or cyclosporin. * Woman with hereditary intolerance to galactose, with lactose lapp deficiency, glucose or galactose malabsorption syndrome
Contact & Investigator
Marianne LERUEZ-VILLE, MD, PhD
STUDY CHAIR
Virology laboratory- reference national Lab for CMV infection -Hôpital Necker-Enfants malades, Paris
Frequently Asked Questions
Who can join the NCT05446571 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnant Women. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05446571 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 46 participants.
Is NCT05446571 currently recruiting?
Yes, NCT05446571 is actively recruiting participants. Contact the research team at ville.yves@gmail.com for enrollment information.
Where is the NCT05446571 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05446571 clinical trial?
NCT05446571 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Marianne LERUEZ-VILLE, MD, PhD at Virology laboratory- reference national Lab for CMV infection -Hôpital Necker-Enfants malades, Paris. The trial plans to enroll 46 participants.