The Third Affiliated Hospital of Guangzhou Medical University
Phase
Phase 4
Started
2024-12-27
Last updated
2026-04-21
Condition(s) studied
Hepatitis B Virus Infection; Pregnant Women
Investigational drug(s) / intervention(s)
TAF
TAF: Taking TAF during the pregnancy
Study summary
The goal of this clinical trial is to learn the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy antiviral therapy for chronic hepatitis B pregnant women.
The main questions it aims to answer are:
The rate of HBV mother-to-child transmission between the TAF and TDF groups. The incidence of birth defects in newborns between the TAF and TDF groups. What medical problems do participants have when taking drug TAF or TDF? The growth and development indices of newborns between the TAF and TDF groups.
Participants will:
Take drug TAF or TDF every day during the pregnacy. Visit the clinic once every 4 weeks for checkups and tests during the pregnancy and every 12 weeks postpartum.
Eligibility
Sex
FEMALE
Min age
20 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria:
Female gender. Age between 20-40 years old. Positive for HBsAg for ≥6 months. Pregnant at 0-24 weeks meeting the 2022 China Chronic Hepatitis B guidelines for antiviral therapy (including but not elevated transaminases, liver cirrhosis, hepatic fibrosis, or extrahepatic manifestations of hepatitis B).
Willingness to take TAF/TDF orally once daily from enrollment until delivery or long-term use.
Good medication compliance.
Exclusion Criteria:
Co-infection with hepatitis A, C, E viruses, other hepatotropic viruses, or HIV.
Liver cirrhosis, liver cancer, or other chronic liver diseases. Significant organ diseases (e.g., heart, lung, or kidney diseases). Autoimmune hepatitis, autoimmune diseases, hypertension, diabetes, or thyroid disorders.
History of pregnancy complications. History of fetal/neonatal growth defects in previous pregnancies. Use of nephrotoxic drugs, corticosteroids, NSAIDs, cytotoxic drugs, or immunomodulators prior to enrollment.
Abnormal ultrasound findings indicating fetal malformations, placental abnormalities, or threatened miscarriage before treatment initiation.
Failure to attend follow-up visits as scheduled.
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Primary outcome measure(s)
Hepatitis B virus Mother-to-infant blocking rate — participant' infants 7 months old test HBsAg and HBV-DNA of the infants
Trial sites (1)
Facility
City
Region
Status
Department of Infectious Diseases, Guangdong Provincial Key Laboratory of Major Obstetric Diseases; Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University,
Guangzhou
Guangdong
More The Third Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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