Hepatitis B Virus Infection; Pregnant Women
Conditions
Brief 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.
Interventions
DRUGTAF
Taking TAF during the pregnancy
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis B virus Mother-to-infant blocking rate | participant' infants 7 months old | test HBsAg and HBV-DNA of the infants |
Secondary
| Measure | Time frame |
|---|---|
| Rate of birth defects | When participants gave birth |
| Incidence of complications and adverse drug reactions during pregnancy | From date of randomization until the date of first documented progression, assessed up to 14 months |
Countries
China
Outcome results
None listed