Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

September 2, 2022 updated by: Hong You, Beijing Friendship Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

No.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100015
        • Beijing Ditan Hospital, Capital Medical University
      • Beijing, Beijing, China
        • Beijing Friendship Hospital, Capital Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital, Southern Medical University
    • Jiangsu
      • Wuxi, Jiangsu, China
        • Wuxi Hisky Medical Technologies Co., Ltd.
    • Shanghai
      • Shanghai, Shanghai, China
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China
        • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Hangzhou Choutu Technology Co.,Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CHB patients with liver biopsy performed at least 1 year after antiviral therapy; or CHB patients with antiviral therapy for at least 1 year content to be performed liver biopsy at enrollment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 to 10 years
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
1 to 10 years
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
1 to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 29, 2018

Primary Completion (ANTICIPATED)

December 31, 2028

Study Completion (ANTICIPATED)

December 31, 2028

Study Registration Dates

First Submitted

October 27, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (ACTUAL)

December 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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