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

Nanfang Hospital, Southern Medical University

Status and phase

Unknown

Phase 4

Conditions

Hepatitis B, Chronic

Mother to Child Transmission

Treatments

Drug: antiviral prophylaxis with Tenofovir Alafenamide Fumarate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05177926

Shield-TAF

Details and patient eligibility

About

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.

Full 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.

Enrollment

330 estimated patients

Sex

Female

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

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