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Clinical Trials in China / NCT07668934
Enrolling by invitation Phase 4

TAF in Early/Middle Pregnancy With CHB

NCT07668934 · tracked via the Priya Life Science China tracker
Sponsor
The Third Affiliated Hospital of Guangzhou Medical University
Phase
Phase 4
Started
2025-03-31
Last updated
2026-06-25

Condition(s) studied

Hepatitis B InfectionPregnant WomenEarly Pregnancy

Investigational drug(s) / intervention(s)

TAFTDF

TAF: Taking TAF from early or middle pregnancy

TDF: Taking TDF from early or middle pregnancy

Study summary

The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * Between the ages of 20 and 40 * HBsAg positive for \>= 6 months * 0-24 week of pregnancy * Meets the indications for antiviral therapy in the 2022 version of the guidelines for the prevention and treatment of chronic hepatitis B * It is planned to use TAF or TDF antiviral therapy until the end of delivery or long-term administration, and follow-up will be carried out in this research institution * Signed informed consent for medication Exclusion Criteria: * Previous use of anti-hepatitis B virus drugs (e.g., entecavir, tenofovir, tenofovir alafenol, emintenofovir, adefovir dipoproxil, telbivudine, etc.) * Concomitant viral hepatitis A, C, E or other hepatotropic virus infection or AIDS * Concomitant cirrhosis, liver cancer or other chronic liver diseases (e.g., alcoholic liver, autoimmune liver disease, G6PD deficiency, etc.) * Patients with heart (such as coronary heart disease, myocardial infarction, heart failure, etc.), lung (such as: lung cancer, chronic obstructive pulmonary disease, tuberculosis, etc.), kidney (such as: renal failure, elevated creatinine, nephritis, nephrotic syndrome, etc.) and other important organ diseases * Chronic diseases such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, anticoagulant antibody syndrome), hypertension, diabetes, thyroid disease, etc * Patients with previous pregnancy complications (such as: gestational hypertension, gestational diabetes, gestational eclampsia, etc.) * Those who have had fetal or neonatal growth and development defects in previous pregnancies * Previous or ongoing use of nephrotoxic medications, glucocorticoids, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, or immunomodulators * Premedication ultrasound showed fetal malformations, fetal development abnormalities, placental abnormalities, threatened abortion, etc

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Third Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

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

Other trials for the same condition

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 NCT07668934 on ClinicalTrials.gov ↗ ← All trials in China