Clinical Trial

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

Study acronym: TOPCHIB
Recruiting Phase 4
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-05-28.
Status change: Not Yet Recruiting → Recruiting 2026-06-25
Trial Details
NCT Number NCT05403047
Lead Sponsor ANRS, Emerging Infectious Diseases
Conditions Hepatitis B Virus - Chronic Active
Enrollment 150 participants
Start Date 2023-08-22
Primary Completion 2027-08 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-29