Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

Precise Prediction System for Clinical Endpoint Events of Chronic Hepatitis B Patients in the Ear of Antiviral Therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03777969

Enrollment

2000

Registered

2018-12-19

Start date

2018-06-29

Completion date

2028-12-31

Last updated

2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis b

Keywords

Chronic Hepatitis B, Liver fibrosis/cirrhosis, HBV-related endpoint events, Precise prediction model

Brief summary

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.

Detailed description

No.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death	1 to 10 years	Incidence of HBV-related clinical endpoint events during follow-ups

Secondary

Measure	Time frame	Description
Predicted probability of HBV-related clinical endpoint events	1 to 10 years	The predicted probability is measured by histological prediction model or non-invasive prediction model
Predicted probability of HBV-induced fibrosis/cirrhosis regression	1 to 10 years	The predicted probability is measured by histological prediction model or non-invasive prediction model
Percentage of HBV-induced liver fibrosis/cirrhosis regression	1 to 10 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

Countries

China

Outcome results