Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
Recruiting now · Phase 4
Conditions studied: Hepatitis B Virus - Chronic Active
In brief
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).
Key facts
- Study ID
- NCT05403047
- Run by
- ANRS, Emerging Infectious Diseases
- People needed
- 150
- Starts
- 2023-08-22
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-06-29
Who can join
Age: 16 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Hôpital Privé de Tokombéré — Tokonbéré, Cameroon (enrolling)
Full record on ClinicalTrials.gov
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