CompletedNot Applicable

Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir - CYMEVALIII STEP1

France7 participantsStarted 2021-06-11

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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/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

What they're measuring

Concentrations reached in fetal blood relative to EC50 of letermovir.

Timeframe: At termination of pregnancy, on average 3 days after inclusion

Trial details

NCT IDNCT04732260

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-05