drugset / Trial / NCT05403047

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

NCT05403047

Phase 4 Recruiting 150 enrolled ANRS, Emerging Infectious Diseases
NaSingle-groupOpen-labelPrevention

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).

Timeline

Start
2023-08-22
Primary completion
2027-08
Completion
2028-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenofovir disoproxil fumarate Small molecule 245 mg