Non-Invasive Model for Fibrosis Regression in HBV Patients

Capital Medical University

Status

Enrolling

Conditions

Liver Fibrosis

Chronic Hepatitis B Virus (HBV) Infection

Treatments

Drug: Nucleos(t)ide Analogs (NA)

Study type

Observational

Funder types

Other

Identifiers

NCT06874127

Z221100007422115 (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment

1,100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.