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ENROLLING BY INVITATION
NCT07542951
PHASE4

TAF vs TDF During the Pregancy

Sponsor: The Third Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-12-27

Completion Date

2029-12-01

Last Updated

2026-04-21

Healthy Volunteers

No

Interventions

DRUG

TAF

Taking TAF during the pregnancy

Locations (1)

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, Guangdong, China