Hepatitis B, Chronic, Mother to Child Transmission
Conditions
Keywords
hepatitis B virus, mother-to-child transmission, antiviral prophylaxis, Tenofovir Alafenamide
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.
Interventions
DRUGantiviral prophylaxis with Tenofovir Alafenamide Fumarate
All participants will receive antiviral prophylaxis with Tenofovir Alafenamide Fumarate for preventing of Mother-to-child transmission of HBV
Sponsors
Gilead Sciences
Tigermed Consulting Co., Ltd
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a single arm study, in which all participants will receive study drug.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactJinlin Hou
Outcome results
None listed