TAF vs TDF During the Pregancy

NCT07542951 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-21

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542951 on ClinicalTrials.gov