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Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection

NCT03343431 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Anti-HBV antiviral prophylaxis

Tenofovir disoproxil fumarate (TDF), one 300 mg tablet once a day from 28 weeks' gestation through two months postpartum

Sponsors & Collaborators

  • Chiang Mai University

    collaborator OTHER

  • Ministry of Health, Thailand

    collaborator OTHER_GOV

  • Ministry of Health, Lao PDR

    collaborator UNKNOWN

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Gonzague Jourdain, MD, PhD · Chiang Mai University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-02
Primary Completion
2023-05-13
Completion
2025-06-30

Countries

  • Laos
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03343431 on ClinicalTrials.gov