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Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand

NCT01745822 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2021-03-05

Study results available
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Summary

Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV). The risk of perinatal transmission of HBV is about 12% when a mother has a high HBV load in her plasma, even if her infant receive specific immunoglobulin and vaccine.

The hypothesis of this study is that a potent antiviral, tenofovir, can decrease HBV load in HBV infected pregnant women and therefore reduce the risk of perinatal transmission/ Pregnant women participating in this study will receive tenofovir or placebo during the last trimester of pregnancy and two months postpartum. The risk of perinatal transmission will be compared between the two groups.

The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.

Conditions

  • Hepatitis B Chronic Infection
  • Pregnancy

Interventions

DRUG

tenofovir disoproxil fumarate

administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum

DRUG

placebo

administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum

Sponsors & Collaborators

Principal Investigators

  • Gonzague Jourdain, MD, PhD · Institut de Recherche pour le Developpement

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-12-31
Completion
2018-10-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01745822 on ClinicalTrials.gov