Traitement prénatal de l'infection congénitale à cytomégalovirus par le letermovir randomisé contre le valaciclovir

Phase 1

• Conditions: Step 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 TOP; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002924-35-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-07
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

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 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

Exclusion Criteria

Step1:
-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

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 <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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified