drugset / Trial / NCT07542951

TAF vs TDF During the Pregancy

NCT07542951

Phase 4 Enrolling by invitation 200 enrolled The Third Affiliated Hospital of Guangzhou Medical University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-27
Primary completion
2028-12-01
Completion
2029-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject tenofovir alafenamide Small molecule