RECRUITINGOBSERVATIONAL

Non-Invasive Model for Fibrosis Regression in HBV Patients

Establishment and Application of a Non-Invasive Dynamic Model for Fibrosis Regression in Patients with Chronic Hepatitis B

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Nucleos(t)ide Analogs (NA)

all patients received NAs

Locations (1)

Beijing Friendship Hospital

Beijing, China