Comparing two hepatitis B medicines taken during pregnancy by women with chronic hepatitis B
Compares TAF and TDF in pregnant women with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: TAF vs TDF During the Pregancy
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant women with long-term hepatitis B who need antiviral treatment. It compares two drugs, TAF and TDF, taken during pregnancy.
- Age
- 20 to 40 years
- Sex
- Women only
- Disease stage
- Pregnant at 0-24 weeks, with chronic hepatitis B (HBsAg positive for 6 months or more) that meets the 2022 China Chronic Hepatitis B guidelines for antiviral therapy.
- Earlier treatment
- Must not have used kidney-harming drugs, corticosteroids, NSAIDs, cell-killing (cytotoxic) drugs or immune-modifying drugs before joining.
- Biomarker or test result
- HBsAg positive for 6 months or more.
Main reasons for not taking part
- Infection with hepatitis A, C, E, other liver viruses, or HIV
- Liver cirrhosis, liver cancer, or other long-term liver disease
- Serious heart, lung or kidney disease
- Autoimmune disease, high blood pressure, diabetes, or thyroid problems
- Past pregnancy complications, or abnormal fetal ultrasound before treatment starts
This trial only enrols pregnant participants. The registry sentence this rests on: 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).
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 40 years old?
Source: NCT07542951, who can take part
Where in China
- 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, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The Third Affiliated Hospital of Guangzhou Medical University
- Trial code
- NCT07542951
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; Failure to attend follow-up visits as scheduled; Abnormal ultrasound findings indicating fetal malformations, placental abnormalities, or threatened miscarriage before treatment initiation; -.