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New hope for pregnant women: drug may stop CMV in unborn babies

NCT ID NCT05446571

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug letermovir can stop cytomegalovirus (CMV) in unborn babies better than the current treatment valaciclovir. Pregnant women with a CMV-infected fetus will take one of the two drugs daily until delivery. The goal is to see if letermovir leads to a negative CMV test in the baby's blood at birth, which could mean fewer health problems later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
letermovir and valaciclovir
What this could lead to
If letermovir works better, it could offer a more effective prenatal treatment to prevent CMV-related birth defects and long-term health problems.
What could go wrong
This is a small, early-stage trial with only 46 participants, so results may not apply to everyone. Both drugs have side effects, and the study is still recruiting, so it's too soon to know if letermovir is truly better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 hyperechogenicity, microcephaly\<-3SD, vermian hypoplasia, porencephaly, lissencephaly, corpus callosum dysgenesis, cystic leukomalacia) * 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 * 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

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Conditions

The condition(s) this trial relates to.

fetal cytomegalovirus syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CMV infected fetuses Pregnant women

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hopital Necker - Enfants malades

    RECRUITING

    Paris, 75015, France

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