Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)

Nanfang Hospital, Southern Medical University330 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

330

Conditions

Hepatitis B, Chronic Mother to Child Transmission

Interventions

antiviral prophylaxis with Tenofovir Alafenamide FumarateDRUG

All participants will receive antiviral prophylaxis with Tenofovir Alafenamide Fumarate for preventing of Mother-to-child transmission of HBV

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant woman aged 20 to 35 years old * 24-26 week of gestation * HBsAg positive more than 6 months and HBeAg positive * HBV DNA\> 200,000 IU/ml * Informed consent is signed voluntarily by both husband and wife * Good compliance and able to be followed up as planned Exclusion Criteria: * Mothers co-infected with HCV and HIV * Evidence of decompensated cirrhosis and liver cancer * Mothers had other organ lesions which would affect patient compliance and follow-up plan * Mothers had history of spontaneous abortion or their children had birth defect or congenital malformation * Mothers received antiviral therapy within 6 months * Mothers had history of kidney injury, CCr \<50ml/min and urine protein test positive (\>300mg/L) * Mothers had history of other chronic diseases and had to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy * The infants' biological fathers are infected with HBV * Symptoms of threatened abortion during early pregnancy * ALT \> 1×upper limit of normal (ULN), or TBIL ≥ 1×ULN or glomerular filtration rate (GFR) \< 90 ml/min, or Albumin (ALB) \< 25 g/L * Fetal malformations detected by B-ultrasound during pregnancy * Participating in other studies

Locations (13)

The First Affiliated Hospital of Jilin University

Changchun, China

RECRUITING

The First People's Hospital of Foshan

Foshan, China

Outcomes

Primary Outcomes

Rate of mother-to-child transmission of HBV

the number of HBV-infected infants relative to all participants enrolled or to all participants who complete follow-up

Time frame: from enrollment to the last infant completes post vaccination serological test (PVST), assessed up to 32 months

Secondary Outcomes

Rate of birth defect of infants

the number of infants with birth defect relative to all participants enrolled

Time frame: from enrollment to the last mother delivery, assessed up to 24 months

Central Contacts

Jinlin Hou

CONTACT

86-20-61641941 jlhousmu@163.com

Data from ClinicalTrials.gov

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