NCT07542951Enrolling by invitationPhase 4
TAF vs TDF During the Pregancy
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 9 Apr 2026
- Start date
- 27 Dec 2024
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
- Diseases
- Hepatitis B
- NCT number
- NCT07542951
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 210
- From 27 Dec 2024 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Abnormal ultrasound findings indicating fetal malformations, placental abnormalities, or threatened miscarriage before treatment initiation.
- \-
Who the study is looking for
- 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.
Age in the registry: 20 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site 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, Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.