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" Prenatal treatment of congenital cytomegalovirus infection with letermovir randomized against valaciclovir (CYMEVAL III)
EU CTIS ID: 2024-512869-14-00
What this study is testing
Step 1: Main objective To measure the Letermovir transplacental transfer in the second trimester and its accumulation in the amniotic fluid and the placenta in the second trimester Primary end point: Concentrations reached in fetal blood relative to EC50 of letermovir. Step 2: Main objective: 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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Step1: -Pregnant woman ≥ 18 years old - in her second trimester of pregnancy - undergoing TOP for any fetal abnormality - no evidence of placental dysfunction. - - 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 Step2: -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, lisencephaly, corpus callosum dysgenesis, cystic leukomalacia, Mega-cisterna magna >10 mm) - 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
You likely can't join if
- Step1: -Participation to another interventional drug trial (category 1) -Subject protected by law under guardianship or curatorship -Woman with creatinine clearance <75 ml/mn/1,73m² -Woman with liver insufficiency (Child Pugh grade C), AST, ALT 5 x ULN, bilirubin 2 x ULN. -Woman with known allergy to Letermovir -Contraindication for the administration of Letermovir listed in the SmPC of Prevymis® -Woman treated by pimozide, ergot alkaloids, dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatine or cyclosporine. -Concomitant administration of millepertuis -Woman with hereditary intolerance to galactose, with lactose lapp deficiency, glucose or galactose malabsorption syndrome Step2: -Participation to another interventional drug trial (category 1) -Subject protected by law under guardianship or curatorship -Maternal CMV infection after 15 weeks -creatinine clearance <75 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 valaciclovirlisted in the SmPC of Prevymis® and Zelitrex® - Women with hypersensitivity to aciclovir -Concomitant administration of millepertuis -woman treated by pimozidee, ergot alkaloids, dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatine or cyclosporine. -Woman with hereditary intolerance to galactose, with lactose lapp deficiency, glucose or galactose malabsorption syndrome
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.