TAF vs TDF During the Pregancy
NCT07542951 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-04-21
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.
Conditions
- Hepatitis B Virus Infection; Pregnant Women
Interventions
- DRUG
-
TAF
Taking TAF during the pregnancy
Sponsors & Collaborators
-
The Third Affiliated Hospital of Guangzhou Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-27
- Primary Completion
- 2028-12-01
- Completion
- 2029-12-01
Countries
- China
Study Locations
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