NCT05403047Active, not recruitingPhase 4
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 23 May 2022
- Start date
- 22 Aug 2023
- Primary completion date
- Aug 2027
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Diseases
- Hepatitis B
- NCT number
- NCT05403047
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From 22 Aug 2023 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- HIV co-infection;
- Women treated for HBV;
- Suspicion of poor monitoring of children's vaccination schedule for HBV (vaccination at birth + boosters);
- Disease or treatment contraindicating the taking of TDF.
Lab values
- Creatinine clearance \<30 ml / min;
Who the study is looking for
- 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
Age in the registry: 16 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Privé de Tokombéré Coordinator of this site? Confirm its status | Tokonbéré | Cameroon | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.