Hepatitis B Virus - Chronic ActivePhase 4TOPCHIBNCT05403047

Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women

A Phase 4 study testing Fumarate, Tenofovir Disoproxil in people with Hepatitis B Virus - Chronic Active, run by ANRS, Emerging Infectious Diseases at 1 site in Cameroon.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 16 years and older, women only
Conditions the study is for: Hepatitis B Virus - Chronic Active
What is being tested?: Fumarate, Tenofovir Disoproxil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteCameroon
Study dates: 22 Aug 2023to Feb 2028
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Cameroon1 site

Hôpital Privé de Tokombéré
Tokonbéré

Other trials in Cameroon

About this study

Official title: Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women Infected With Hepatitis B Virus (HBeAg Positive or With a High Viral Load) and Whose Newborns Had Been Vaccinated at Birth

Pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate (TDF) from the 28th week of amenorrhoea until 6 weeks after delivery. Their newborns will receive the hepatitis B vaccine, starting with one dose at birth and followed by three booster doses, according to the Expanded Programme on Immunisation.

The investigators hypothesise that a short course of TDF could greatly reduce the risk of HBV MTCT in pregnant women at high risk of MTCT (HBeAg positive or with high viral load).

Read the detailed description

This is a prospective, single-arm, open-label, descriptive, phase IV clinical trial in HBsAg and HBeAg positive pregnant women. Eligible pregnant women will receive 245 mg of tenofovir disoproxil fumarate once daily from 28 weeks of pregnancy until 6 weeks after delivery. Newborns will receive the hepatitis B vaccine, starting with one dose at birth, followed by three booster doses, in accordance with the expanded programme of vaccination.

The study aims to show that the addition of maternal antiviral treatment to vaccination at birth followed by three booster doses can be favourably considered in the context where vaccination alone is not sufficient to prevent transmission of the hepatitis B virus from mother to child. A total of 150 pregnant women will be included in the Tokombéré district.

Conditions: Hepatitis B Virus - Chronic Active
Being tested: Fumarate, Tenofovir Disoproxil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fumarate, Tenofovir DisoproxilDrug
Also called TDF
all participants receive the intervention

Study groups in NCT05403047
Study group	Role	What they receive
pregnant woman - tenofovir	Other	Participants will be started on tenofovir disoproxil fumarate (TDF) 245 mg one tablet per day from week 28 of pregnancy until 6 weeks postpartum. Receives: Drug: Fumarate, Tenofovir Disoproxil

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of children with HBsAg positive at 9-12 months of life (W36 - W48) in the study population,
Proportion of HBsAg-positive children between 9 and 12 months of age in the study population, assessed by an automated test (mini VIDAS)
Measured: measured between 36 and 48 weeks of life of the child of the mothers included in the study

Secondary outcomes (7)

Proportion of eligible women who accepted the intervention among eligible women offered the intervention (acceptance rate)
Proportion of women who took TDF continuously from the 7th month of pregnancy to 8 weeks postpartum (for at least 4 months) among women who accepted the intervention
Measured: measured from 7 months of pregnancy to 8 weeks postpartum
Compliance with treatment
Compliance with treatment, estimated by self-report questionnaire and pill count
Measured: from 28 weeks of pregnancy to 8 weeks postpartum
Progression of viral load
Progression of viral load, HBsAg, HBeAg, HBcr and anti-HBe seroconversion in pregnant women during the treatment period (measured at inclusion and at the end of the TDF treatment)
Measured: measured from 24 weeks of pregnancy until the end of treatment
Estimate the protection rate of children with anti-HBs antibody level > 10 mIU/mL
Proportion of children with anti-HBs Ac > 10 mIU/ml at 9-12 months / total number of children in the study.
Measured: measured between 36 and 48 weeks of life of the child of the mothers included in the study
Assess the clinical and biological tolerance of TDF administration in mothers and children
Nature, number, frequency and intensity of adverse events in women; Nature, number, frequency, and intensity of adverse events in mothers and children and whether they are related to TDF use
Measured: measured from 28 weeks of pregnancy until the end of treatment
Assess the rate of women requiring extended treatment after delivery
Proportion of cytolytic or virological rebounds (with detectable viral load) after cessation of treatment estimated by measurement of ALT and HBV viral load at 12 weeks and 24 weeks postpartum when they previously had a non-detectable viral load at 8 weeks postpartum
Measured: Assess at 12 and 24 weeks postpartum
To assess the cost-effectiveness of the intervention (compared to vaccination alone, without hepatitis B immune globulin (Ig-anti HBV))
Incremental cost-effectiveness ratio of the intervention compared to the situation where children receive vaccination only (HBV vaccination at birth + pentavalent)
Measured: To evaluate throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 2023Feb 2028

First posted3 Jun 2022
Study start22 Aug 2023
Primary completionAug 2027 (estimated)
Study completionFeb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis B Virus - Chronic ActiveStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05403047
Sponsor's protocol ID: ANRS 12417 TOPCHIB
Acronym: TOPCHIB
Status last verified: Oct 2026
First submitted: 23 May 2022
Last updated: 14 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No