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

Hepatitis B, Chronic Clinical Trial

Official title:

A Prospective, Multi-center, Cohort Study 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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05177926
• Other study ID #: Shield-TAF
• Status: Recruiting
• Phase: Phase 4
• Start date: April 4, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jinlin Hou
• Phone: 86-20-61641941
• Email: jlhousmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Mother to Child Transmission

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Jilin University	Chang chun
China	The First People's Hospital of Foshan	Foshan
China	Guangdong Maternal and Child Care Hospital	Guangzhou
China	Guangzhou No. 8 People's Hospital	Guangzhou
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	The Fifth Affiliated Hospital of Southern Medical University	Guangzhou
China	Zhujiang Hospital, Southern Medical University	Guangzhou
China	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine	Hangzhou
China	Xixi Hospital of Hangzhou	Hangzhou
China	The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing)	Nanjing
China	Shanghai Public Health Clinical Center	Shanghai
China	Shenzhen Baoan Maternal and Child Care Hospital	Shenzhen
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an

Sponsors (3)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Gilead Sciences, Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from enrollment to the last infant completes post vaccination serological test (PVST), assessed up to 32 months
Secondary	Rate of birth defect of infants	the number of infants with birth defect relative to all participants enrolled	from enrollment to the last mother delivery, assessed up to 24 months