TAF vs TDF During the Pregancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TAF.
- Who it may be relevant to
- Registry conditions: Hepatitis B Virus Infection; Pregnant Women. Basic parameters: 20 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective RCT Study on the Efficacy and Safety of TAF vs TDF in Early and Middle Pregnancy Antiviral Therapy for Chronic Hepatitis B Pregnant Women
Overview
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
- Drug TAF
Taking TAF during the pregnancy
Primary outcome measures
- Hepatitis B virus Mother-to-infant blocking rate [Time frame: participant' infants 7 months old]
Secondary outcome measures (2)
- Rate of birth defects [Time frame: When participants gave birth]
- Incidence of complications and adverse drug reactions during pregnancy [Time frame: From date of randomization until the date of first documented progression, assessed up to 14 months]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Infectious Diseases, Guangdong Provincial Key Laboratory of Major Obstetric — Guangzhou
Identifiers
NCT: NCT07542951 · [2024]489