A Phase 4 interventional study of Fumarate, Tenofovir Disoproxil in Hepatitis B Virus - Chronic Active, sponsored by ANRS, Emerging Infectious Diseases. Active, not recruiting at 1 site in Cameroon. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 4, Interventional, and Prevention
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).
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.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 150 is close to the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be started on tenofovir disoproxil fumarate (TDF) 245 mg one tablet per day from week 28 of pregnancy until 6 weeks postpartum.
Drug: Fumarate, Tenofovir Disoproxil
all participants receive the intervention
Also known as: TDF
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)
Time frame: measured between 36 and 48 weeks of life of the child of the mothers included in the study
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
Time frame: measured from 7 months of pregnancy to 8 weeks postpartum
Compliance with treatment
Compliance with treatment, estimated by self-report questionnaire and pill count
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: To evaluate throughout the study
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenofovir
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