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

Phase 4

• Conditions: Hepatitis B, Chronic; Mother to Child Transmission
• Interventions: Drug: antiviral prophylaxis with Tenofovir Alafenamide Fumarate

• Registration Number: NCT05177926
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2019-12-31
• Study Start: 2021-04-04
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-15
• Last Update Submitted: 2021-12-15
• Study First Posted: 2022-01-05
• Last Update Posted: 2022-01-05
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
antiviral prophylaxis with Tenofovir Alafenamide Fumarate (TAF)	antiviral prophylaxis with Tenofovir Alafenamide Fumarate	All participants will receive oral Tenofovir Alafenamide Fumarate 25mg, daily, at gestational 27-29 week until delivery.

Primary Outcome Measures

Name	Time	Method
Rate of mother-to-child transmission of HBV	from enrollment to the last infant completes post vaccination serological test (PVST), assessed up to 32 months	the number of HBV-infected infants relative to all participants enrolled or to all participants who complete follow-up

Secondary Outcome Measures

Name	Time	Method
Rate of birth defect of infants	from enrollment to the last mother delivery, assessed up to 24 months	the number of infants with birth defect relative to all participants enrolled

Trial Locations

Locations (13)

Guangdong Maternal and Child Care Hospital; 🇨🇳 Guangzhou, China

The Fifth Affiliated Hospital of Southern Medical University; 🇨🇳 Guangzhou, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China

Xixi Hospital of Hangzhou; 🇨🇳 Hangzhou, China

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, China

Shenzhen Baoan Maternal and Child Care Hospital; 🇨🇳 Shenzhen, China

The First Affiliated Hospital of Jilin University; 🇨🇳 Chang chun, China

Guangzhou No. 8 People's Hospital; 🇨🇳 Guangzhou, China

The First People's Hospital of Foshan; 🇨🇳 Foshan, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, China

Zhujiang Hospital, Southern Medical University; 🇨🇳 Guangzhou, China

The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing); 🇨🇳 Nanjing, China