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

NCT04732260 | Completed DMC

• 2 other identifiers: APHP1805922020-002924-35
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pregnant Women Undergoing TOP; TOP - Failed Attempted Termination of Pregnancy

Keywords

Cytomegalovirus; Pregnant women

Outcome Measures

Primary Outcomes (1)

• Concentrations reached in fetal blood relative to EC50 of letermovir.

  At termination of pregnancy, on average 3 days after inclusion

Study Arms (1)

letermovir

EXPERIMENTAL

Maternal administration of 1 tablet of Letermovir (240 mg or 480 mg /day) during 3 days before TOP

Drug: Letermovir

Interventions

Letermovir DRUG

Each patient will receive 1 tablet of Letermovir (240 mg or 480 mg /day) during 3 days before TOP. 5 women will receive 240 mg. 5 women will receive 480 mg.

letermovir

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker - Enfants malades

Paris, 75015, France

Location

Related Publications (1)

• Faure Bardon V, Peytavin G, Le MP, Guilleminot T, Elefant E, Stirnemann J, Leruez-Ville M, Ville Y. Placental transfer of Letermovir & Maribavir in the ex vivo human cotyledon perfusion model. New perspectives for in utero treatment of congenital cytomegalovirus infection. PLoS One. 2020 Apr 30;15(4):e0232140. doi: 10.1371/journal.pone.0232140. eCollection 2020.

  PMID: 32353010 BACKGROUND

MeSH Terms

Interventions

letermovir

Study Officials

• Marianne LERUEZ-VILLE, PhD & MD

  Virology laboratory- reference national Lab for CMV infection -Hôpital Necker-Enfants malades, Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 1, 2021
• Study Start: June 11, 2021
• Primary Completion: November 5, 2021
• Study Completion: November 12, 2021
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)