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Active, Not Recruiting

NCT Number: NCT03777969

Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Ditan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

No.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death

    Time frame: 1 to 10 years

    Incidence of HBV-related clinical endpoint events during follow-ups

Secondary outcomes

  1. Predicted probability of HBV-related clinical endpoint events

    Time frame: 1 to 10 years

    The predicted probability is measured by histological prediction model or non-invasive prediction model

  2. Predicted probability of HBV-induced fibrosis/cirrhosis regression

    Time frame: 1 to 10 years

    The predicted probability is measured by histological prediction model or non-invasive prediction model

  3. Percentage of HBV-induced liver fibrosis/cirrhosis regression

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

  • Beijing Ditan Hospital
  • Hangzhou Choutu Technology Co.,Ltd.
  • Nanfang Hospital, Southern Medical University
  • Ruijin Hospital
  • ShuGuang Hospital
  • Wuxi Hisky Medical Technologies Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Dec 19, 2018
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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