Clinical Trial

Non-Invasive Model for Fibrosis Regression in HBV Patients

Recruiting
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Record status
This record was last updated March 13, 2025 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
A total of 1000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are retrospectively enrolled. All the patients received NAs treatment. Blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers were collected. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death were collected. Fibrosis regression prediction model based on dynamic changes in liver stiffness will be developed based on the retrospective cohort. An independent cohort of CHB patients with liver biopsy performed at least 1 year after antiviral therapy will be retrospectively enrolled for model validation.
Trial Details
NCT Number NCT06874127
Lead Sponsor Beijing Friendship Hospital
Conditions Chronic Hepatitis B Virus (HBV) Infection, Liver Fibrosis
Enrollment 1,100 participants
Start Date 2024-02-01
Primary Completion 2026-02-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-13