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Compares treatment options for Pregnant Women
Official title Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir
ClinicalTrials.gov ID: NCT05446571
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pregnant women.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigators' hypothesis is that maternal treatment with Letermovir will inhibit fetal CMV replication better than Valaciclovir in infected fetuses and lead to a higher proportion of negative CMV PCR at birth in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP). The main objective is to demonstrate that Letermovir administered to women carrying a CMV infected fetus following a maternal infection of the first trimester increases the proportion of neonates with a negative CMV PCR in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP) compared to Valaciclovir.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pregnant woman ≥ 18 years old,
- CMV infection in the 1st trimester
- with an infected fetus at 15 -28 weeks (positive CMV PCR in the amniotic fluid) With a fetus presenting without any severe cerebral ultrasound...
- affiliation to a social security regime//health insurance
- Given consent for the study
You likely can't join if
- Participation to another treatment drug trial (category 1)
- Subject protected by law under guardianship or curatorship
- Maternal CMV infection after 15 weeks'
- Creatinine clearance \<50 ml/mn/1,73m²
- Liver insufficiency (Child Pugh grade C), AST, ALT 5 x ULN, bilirubin 2 x ULN.
- Woman with known allergy to Letermovir or Valaciclovir
See the full eligibility criteria
- Pregnant woman ≥ 18 years old,
- CMV infection in the 1st trimester
- with an infected fetus at 15 -28 weeks (positive CMV PCR in the amniotic fluid) With a fetus presenting without any severe cerebral ultrasound feature (ventriculomegaly ≥15 mm, hydrocephalus, periventricular...
- 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
- Participation to another treatment drug trial (category 1)
- Subject protected by law under guardianship or curatorship
- Maternal CMV infection after 15 weeks'
- Creatinine clearance \<50 ml/mn/1,73m²
- Liver insufficiency (Child Pugh grade C), AST, ALT 5 x ULN, bilirubin 2 x ULN.
- Woman with known allergy to Letermovir or Valaciclovir
- Contraindication for the administration of Letermovir and Valaciclovir listed in the SmPC of Prevymis® and Zelitrex®
- Women with hypersensitivity to aciclovir
- Concomitant administration of St John's wort
- Woman treated by pimozide, ergot alkaloids, dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatin or cyclosporin.
- Woman with hereditary intolerance to galactose, with lactose lapp deficiency, glucose or galactose malabsorption syndrome
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.