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Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA.


Clinical Trial Description

This is a single-arm multicenter, prospective, clinical study, aiming to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA. 330 HBV-infected mothers with high level HBV DNA will be enrolled and receive Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of HBV. Demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, HBV serologic marker tests, HBV DNA tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, Apgar score and any major birth defect), breastfeeding and post vaccination serological test for infants at 7-12 months of age are collected. A mobile health application called "SHIELD" is used in this study to collect data and provide support for communication between mothers and their doctors. All laboratory test reports, questionnaires and other relevant information are uploaded into SHIELD. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05177926
Study type Interventional
Source Nanfang Hospital of Southern Medical University
Contact Jinlin Hou
Phone 86-20-61641941
Email [email protected]
Status Recruiting
Phase Phase 4
Start date April 4, 2021
Completion date December 31, 2023

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