Clinical trial NCT05177926: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Mother to Child Transmission
Keywords: hepatitis B virus
mother-to-child transmission
antiviral prophylaxis
Tenofovir Alafenamide
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: Tigermed Consulting Co., Ltd
First posted: 2022-01-05
Enrollment: 330
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm study, in which all participants will receive study drug.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of mother-to-child transmission of HBV
timeFrame: from enrollment to the last infant completes post vaccination serological test (PVST), assessed up to 32 months
Secondary outcomes:
measure: Rate of birth defect of infants
timeFrame: from enrollment to the last mother delivery, assessed up to 24 months
Other outcomes:
Locations:
city: Chang chun
country: China
facility: The First Affiliated Hospital of Jilin University
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Guangzhou
country: China
facility: Guangdong Maternal and Child Care Hospital
city: Guangzhou
country: China
facility: Guangzhou No. 8 People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Southern Medical University
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Xixi Hospital of Hangzhou
city: Nanjing
country: China
facility: The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing)
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shenzhen
country: China
facility: Shenzhen Baoan Maternal and Child Care Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jinlin Hou
role: STUDY_CHAIR
References: