TAF vs TDF During the Pregancy

NCT07542951 · tracked via the Priya Life Science China tracker

Sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Phase

Phase 4

Started

2024-12-27

Last updated

2026-10-16

Condition(s) studied

Hepatitis B Virus Infection; Pregnant Women

Investigational drug(s) / intervention(s)

TAF

TAF: Taking TAF during the pregnancy

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.

Eligibility

Sex

FEMALE

Min age

20 Years

Max age

40 Years

Healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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. Abnormal ultrasound findings indicating fetal malformations, placental abnormalities, or threatened miscarriage before treatment initiation. Failure to attend follow-up visits as scheduled. \-

Primary outcome measure(s)

Hepatitis B virus Mother-to-infant blocking rate — participant' infants 7 months old
test HBsAg and HBV-DNA of the infants

Trial sites (1)

Facility	City	Region	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,	Guangzhou	Guangdong

More The Third Affiliated Hospital of Guangzhou Medical University trials in China

Planned Delivery at 37 Versus 36 Weeks in Pregnancies With Placenta Previaand Accreta Recruiting

The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center Recruiting

The Efficacy of Vosevi in Treating DAA-experienced Patients Recruiting

Dynamic Monitoring of ctDNA and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery Recruiting

Maternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07542951 on ClinicalTrials.gov ↗ ← All trials in China