Clinical Trial

Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection

Active, Not Recruiting Phase 3
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Summary
Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months following delivery. Their infants will receive hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2017-11-11; most recent amendment 2025-05-26.
Status change: Recruiting → Active, Not Recruiting 2021-04-27
Status change: Not Yet Recruiting → Recruiting 2018-08-15
Trial Details
NCT Number NCT03343431
Lead Sponsor Institut de Recherche pour le Developpement
Collaborators: Chiang Mai University, Ministry of Health, Thailand, Ministry of Health, Lao PDR
Conditions Hepatitis B, Pregnancy
Enrollment 504 participants
Start Date 2018-08-02
Primary Completion 2023-05-13 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-30