Prenatal treatment of congenital cytomegalovirus infection with letermovir randomized against valaciclovir (CYMEVAL III)
- Conditions
- Diseases [C] - Virus Diseases [C02]Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2024-512869-14-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 46
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method