Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir - STEP 1 (CYMEVAL3-STEP1)

• Status: Recruiting
• Trial end date: 2028-02-01
• Target enrollment: 0
• Participant gender: Female

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 is probable that the transplacental passage in the second trimester is in the same range than the one found in the 2th trimester, it needs to be confirmed. The study will be divided in 2 steps: step 1 will study the Letermovir transplacental transfer in the second trimester and step 2 will test the efficacy of letermovir to inhibit replication in infected fetuses.

Main objective To measure the Letermovir transplacental transfer in the second trimester and its accumulation in the amniotic fluid and the placenta in the second trimester

Primary end point:

Concentrations reached in fetal blood relative to EC50 of letermovir.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Letermovir

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

Exclusion Criteria:

• Participation to another interventional drug trial (category 1)

• Subject protected by law under guardianship or curatorship

• Woman with creatinine clearance <75 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