Non-Invasive Model for Fibrosis Regression in HBV Patients

Recruiting

• Conditions: Chronic Hepatitis B Virus (HBV) Infection; Liver Fibrosis
• Interventions: Drug: Nucleos(t)ide Analogs (NA)

• Registration Number: NCT06874127
• Lead Sponsor: Beijing Friendship Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2025-02-26
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-02-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective cohort-derivation cohort	Nucleos(t)ide Analogs (NA)	-
Retrospective cohort-validation cohort	Nucleos(t)ide Analogs (NA)	-

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of non-invasive model for fibrosis regression	5 years	Liver fibrosis regression was defined as decrease \>= 1 point by Ishak fibrosis scoring system (range from 0 to 6, higher values represent a worse outcome) or Predominantly Regressive in P-I-R ( predominantly progressive, indeterminate and predominately regressive) score

Secondary Outcome Measures

Name	Time	Method
Incidence of HBV-related clinical endpoint events	7 years	clinical endpoint event includes: liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death
Percentage of HBV-induced liver fibrosis regression	5 years	Liver fibrosis regression was defined as decrease \>= 1 point by Ishak fibrosis scoring system (range from 0 to 6, higher values represent a worse outcome) or Predominantly Regressive in P-I-R ( predominantly progressive, indeterminate and predominately regressive) score
AUROC of non-invasive model for fibrosis regression	5 years	Liver fibrosis regression was defined as decrease \>= 1 point by Ishak fibrosis scoring system (range from 0 to 6, higher values represent a worse outcome) or Predominantly Regressive in P-I-R ( predominantly progressive, indeterminate and predominately regressive) score
Sensitivity of non-invasive model for fibrosis regression	5 years	Liver fibrosis regression was defined as decrease \>= 1 point by Ishak fibrosis scoring system (range from 0 to 6, higher values represent a worse outcome) or Predominantly Regressive in P-I-R ( predominantly progressive, indeterminate and predominately regressive) score
Specificity of non-invasive model for fibrosis regression	5 years	Liver fibrosis regression was defined as decrease \>= 1 point by Ishak fibrosis scoring system (range from 0 to 6, higher values represent a worse outcome) or Predominantly Regressive in P-I-R ( predominantly progressive, indeterminate and predominately regressive) score

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, China