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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Gilead Sciences; Tigermed Consulting Co., Ltd
• Treatments: Antiviral Agents; Tenofovir

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