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

NCT04732260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-03-31

No results posted yet for this study

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

Interventions

DRUG

Letermovir

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.

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Marianne LERUEZ-VILLE, PhD & MD · Virology laboratory- reference national Lab for CMV infection -Hôpital Necker-Enfants malades, Paris

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2021-11-05
Completion
2021-11-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732260 on ClinicalTrials.gov