Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

Capital Medical University

Status: Active, not recruiting

Conditions: Chronic Hepatitis b

Study type: Observational

Funder types: Other

Identifiers

NCT03777969

2018ZX10302204-001

Details and patient eligibility

About

A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are enrolled. All the patients will receive original antiviral treatment for the following 10 years. Patients will be assessed at baseline and at every six months for 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. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death, will be collected during follow-up.

Full description

No.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Group 1: Patients with history of HBV-related clinical endpoint events

Inclusion Criteria:

• No age limit;
• Male or female;
• Patients with liver biopsy performed at least 1 year after antiviral therapy; patients with history of clinical endpoint events (decompensated cirrhosis, hepatocellular carcinoma, liver transplantation or liver-related death) after liver biopsy;
• 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.

Group 2: Patients without history of clinical endpoint events

Inclusion Criteria:

• No age limit;
• Male or female;
• Patients with liver biopsy performed at least 1 year after antiviral therapy; or chronic hepatitis B (CHB) patients with antiviral therapy at least 1 year content to be performed liver biopsy at enrollment;
• Patients with liver biopsy or liver stiffness or APRI before antiviral treatment;
• Agree to be followed up regularly;
• Signature of informed consent.

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;
• Patients with HCV or 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, exclude who were cured;
• 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.