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Could a short course of antiviral drugs stop hepatitis b passing from mother to child?

NCT ID NCT05403047

Disease control Sponsor: ANRS, Emerging Infectious Diseases 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This trial tests whether giving the antiviral drug tenofovir disoproxil fumarate (TDF) to pregnant women with active hepatitis B can prevent the virus from spreading to their babies. The women take TDF from the 28th week of pregnancy until six weeks after giving birth, and all newborns receive the hepatitis B vaccine starting at birth. The study focuses on women at highest risk of passing the virus—those with a positive HBeAg test or very high viral load—and will check if the babies are still virus-free at 9 to 12 months old.

What this could mean

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

Active substance
tenofovir disoproxil fumarate (TDF)
What this could lead to
If it works, this approach could greatly reduce the number of babies born with chronic hepatitis B in high-risk regions.
What could go wrong
This is a single-site, mid-sized trial; results may not apply everywhere. TDF can cause side effects like kidney issues or bone loss, though short-term use in pregnancy is generally well-tolerated.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

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

Started

Aug 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

16 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 women with a term of less than 24 weeks of amenorrhea; * HBsAg positive ; * HBeAg positive or HBeAg negative with a high viral load ( \> 200 000 UI/ml) ; * 16 years old or more on the inclusion day ; * Signature of free and informed consent (for pregnant women aged 16 to 21, the participant's consent as well as the authorization of a parent/adult husband/ legal tutor will be collected) which also includes consent for the children Exclusion criteria : * HIV co-infection; * Women treated for HBV; * Creatinine clearance \<30 ml / min; * Suspicion of poor monitoring of children's vaccination schedule for HBV (vaccination at birth + boosters); * Disease or treatment contraindicating the taking of TDF.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

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

Hepatitis B virus - chronic active

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

  • Hôpital Privé de Tokombéré

    RECRUITING

    Tokonbéré, Cameroon

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