Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)
Primary Purpose
Hepatitis B, Chronic, Mother to Child Transmission
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
antiviral prophylaxis with Tenofovir Alafenamide Fumarate
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B, Chronic focused on measuring hepatitis B virus, mother-to-child transmission, antiviral prophylaxis, Tenofovir Alafenamide
Eligibility Criteria
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
Sites / Locations
- The First Affiliated Hospital of Jilin UniversityRecruiting
- The First People's Hospital of FoshanRecruiting
- Guangdong Maternal and Child Care HospitalRecruiting
- Guangzhou No. 8 People's Hospital
- Nanfang Hospital, Southern Medical UniversityRecruiting
- The Fifth Affiliated Hospital of Southern Medical University
- Zhujiang Hospital, Southern Medical University
- Affiliated Hangzhou First People's Hospital, Zhejiang University School of MedicineRecruiting
- Xixi Hospital of Hangzhou
- The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing)Recruiting
- Shanghai Public Health Clinical CenterRecruiting
- Shenzhen Baoan Maternal and Child Care HospitalRecruiting
- The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
antiviral prophylaxis with Tenofovir Alafenamide Fumarate (TAF)
Arm Description
All participants will receive oral Tenofovir Alafenamide Fumarate 25mg, daily, at gestational 27-29 week until delivery.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Rate of birth defect of infants
the number of infants with birth defect relative to all participants enrolled
Full Information
NCT ID
NCT05177926
First Posted
December 31, 2019
Last Updated
December 15, 2021
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Gilead Sciences, Tigermed Consulting Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05177926
Brief Title
Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Gilead Sciences, Tigermed Consulting Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic, Mother to Child Transmission
Keywords
hepatitis B virus, mother-to-child transmission, antiviral prophylaxis, Tenofovir Alafenamide
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
This is a single arm study, in which all participants will receive study drug.
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
antiviral prophylaxis with Tenofovir Alafenamide Fumarate (TAF)
Arm Type
Other
Arm Description
All participants will receive oral Tenofovir Alafenamide Fumarate 25mg, daily, at gestational 27-29 week until delivery.
Intervention Type
Drug
Intervention Name(s)
antiviral prophylaxis with Tenofovir Alafenamide Fumarate
Intervention Description
All participants will receive antiviral prophylaxis with Tenofovir Alafenamide Fumarate for preventing of Mother-to-child transmission of HBV
Primary Outcome Measure Information:
Title
Rate of mother-to-child transmission of HBV
Description
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 Outcome Measure Information:
Title
Rate of birth defect of infants
Description
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
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant woman is eligible for mother-to-child transmission study.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinlin Hou
Phone
86-20-61641941
Email
jlhousmu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinlin Hou
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Jilin University
City
Chang chun
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Jiang
Facility Name
The First People's Hospital of Foshan
City
Foshan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honglian Bai
Facility Name
Guangdong Maternal and Child Care Hospital
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhong Xia
Facility Name
Guangzhou No. 8 People's Hospital
City
Guangzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinlin Hou
Facility Name
The Fifth Affiliated Hospital of Southern Medical University
City
Guangzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhujiang Hospital, Southern Medical University
City
Guangzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Jin
Facility Name
Xixi Hospital of Hangzhou
City
Hangzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing)
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guorong Han
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yan
Facility Name
Shenzhen Baoan Maternal and Child Care Hospital
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingren Zhao
12. IPD Sharing Statement
Plan to Share IPD
No
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Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)
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