CTIS2024-512869-14-00进行中（未招募）1 期
CYMEVALIII - Prenatal treatment of congenital cytomegalovirus infection with letermovir randomized against valaciclovir (CYMEVAL) III - APHP180592
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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
排除标准
- •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
研究者
相似试验
进行中（未招募）
1 期
Traitement prénatal de l'infection congénitale à cytomégalovirus par le letermovir randomisé contre le valaciclovirStep 1: Maternal administration of 1 tablet of Letermovir (240 mg or 480 mg /day) during 3 days before TOPStep 2: Maternal daily administration of 240 or 480 milligrams of letermovir (1x240 mg-tablets) or (1x480 mg-tablets) (the dose will be choosen depending on the results obtained on step 1) up-until delivery or TOPEUCTR2020-002924-35-FRASSISTANCE PUBLIQUE HÔPITAUX DE PARIS56
进行中（未招募）
不适用
Traitement in utero de l’infection congénitale à cytomegalovirus (CMV) par valaciclovir : essai prospectif randomisé contre placebo - CYMEVA'infection par cytomégalovirus chez la femme enceinte.MedDRA version: 8.1Level: PTClassification code 10011828Term: L'Infection à CytomégalovirusEUCTR2007-005525-29-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
尚未招募
不适用
establishment of screenig for congenital cytomegalovirus infection in newborns and analysis of clinical features of infected newbornsnewbornsJPRN-UMIN000002125Kobe University Graduate School of Medicine, department of Obstetrics and Gynecology1,200
招募中
Unknown
Antenatal cytomegalovirus (CMV) screening pilot studyMaternal primary infection with cytomegalovirusReproductive Health and Childbirth - Antenatal careACTRN12623000710628niversity of Melbourne70
已完成
4 期
In Utero Treatment of Cytomegalovirus congénitale Infection With ValacyclovirFoetuses InfectionCytomegalovirus (CMV)InfectionNCT01651585Assistance Publique - Hôpitaux de Paris41