EUCTR2020-002924-35-FR
Active, not recruiting
Phase 1
Prenatal treatment of congenital cytomegalovirus infection with letermovir randomized against valaciclovir - CYMEVAL III
ConditionsStep 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 TOPTherapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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
- Sponsor
- ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS
- Enrollment
- 56
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-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)
Exclusion Criteria
- •\-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\)
Outcomes
Primary Outcomes
Not specified
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