Status:
COMPLETED
Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir - CYMEVALIII STEP1
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pregnant Women Undergoing TOP
TOP - Failed Attempted Termination of Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
In the model of the perfused cotyledon, Letermovir crosses the placenta to reach appropriate fetal concentration. The cotyledon model can only be performed in the third trimester placenta. Although it...
Detailed Description
The eligible population of step 1 will be pregnant women in their second trimester of pregnancy and undergoing TOP for any fetal abnormality and no evidence of placental dysfunction. Letermovir (LTM)...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04732260
Start Date
June 11 2021
End Date
November 12 2021
Last Update
September 8 2025
Active Locations (1)
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1
Hôpital Necker - Enfants malades
Paris, France, 75015