Actively Recruiting

Age: 18Years +
All Genders
NCT06874127

Non-Invasive Model for Fibrosis Regression in HBV Patients

Led by Beijing Friendship Hospital · Updated on 2025-03-13

1100

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Non-Invasive Model for Fibrosis Regression in HBV Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with liver biopsy performed at least 1 year after antiviral therapy
  • Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment
Not Eligible

You will not qualify if you...

  • Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy
  • Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases
  • Patients with malignant lesion on liver image
  • Patients with other uncured malignant tumors
  • Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases
  • Pregnant or lactating women
  • Patients with any other reasons not suitable for the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Beijing Friendship Hospital

Beijing, China

Actively Recruiting

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Research Team

Y

Yameng Sun

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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