Prenatal treatment of congenital cytomegalovirus infection with letermovir randomized against valaciclovir - CYMEVAL III

ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS0 个研究点目标入组 56 人开始时间: 2020年10月7日最近更新: 2024年7月29日

适应症

试验速览

暂无简介。

•-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
•-Pregnant woman = 18 years old,
•- CMV infection in the 1st trimester
•- with an infected fetus at 18 -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)
•- 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 46
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 56
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Participation to another interventional drug trial (category 1)
•-Subject protected by law under guardianship or curatorship
•-Woman with creatinine clearance <50 ml/mn
•-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
•-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
•-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®
•-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

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