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

NCT05177926 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: Shield-TAF
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 13

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.

Conditions

Hepatitis B, Chronic; Mother to Child Transmission

Keywords

hepatitis B virus; mother-to-child transmission; antiviral prophylaxis; Tenofovir Alafenamide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of birth defect of infants

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

Study Arms (1)

antiviral prophylaxis with Tenofovir Alafenamide Fumarate (TAF)

OTHER

All participants will receive oral Tenofovir Alafenamide Fumarate 25mg, daily, at gestational 27-29 week until delivery.

Drug: antiviral prophylaxis with Tenofovir Alafenamide Fumarate

Interventions

antiviral prophylaxis with Tenofovir Alafenamide Fumarate DRUG

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

antiviral prophylaxis with Tenofovir Alafenamide Fumarate (TAF)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Pregnant woman is eligible for mother-to-child transmission study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant woman aged 20 to 35 years old
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Gilead Sciences: collaborator
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (13)

The First Affiliated Hospital of Jilin University

Changchun, China

RECRUITING

The First People's Hospital of Foshan

Foshan, China

RECRUITING

Guangdong Maternal and Child Care Hospital

Guangzhou, China

RECRUITING

Guangzhou No. 8 People's Hospital

Guangzhou, China

ACTIVE NOT RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, China

RECRUITING

The Fifth Affiliated Hospital of Southern Medical University

Guangzhou, China

ACTIVE NOT RECRUITING

Zhujiang Hospital, Southern Medical University

Guangzhou, China

ACTIVE NOT RECRUITING

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

Xixi Hospital of Hangzhou

Hangzhou, China

ACTIVE NOT RECRUITING

The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing)

Nanjing, China

RECRUITING

Shanghai Public Health Clinical Center

Shanghai, China

RECRUITING

Shenzhen Baoan Maternal and Child Care Hospital

Shenzhen, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinlin Hou

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Central Study Contacts

Jinlin Hou

CONTACT

86-20-61641941; jlhousmu@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Director

Model Details: This is a single arm study, in which all participants will receive study drug.

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 5, 2022
• Study Start: April 4, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)