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Active Not Recruiting
NCT05403047
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
Conditions: Hepatitis B Virus - Chronic Active
Sex: Female
Ages: 16 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 150
Sponsor: ANRS, Emerging Infectious Diseases
Location: Hôpital Privé de Tokombéré Tokonbéré
Summary
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).
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT05403047). StuddyBuddy aggregates publicly available trial information.