Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

Active, not recruiting

• Conditions: Chronic Hepatitis b

• Registration Number: NCT03777969
• Lead Sponsor: Beijing Friendship Hospital

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.

Study Timeline

• Study Start: 2018-06-29
• Study First Submitted: 2018-10-27
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-19
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-06
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Wuxi Hisky Medical Technologies Co., Ltd.; 🇨🇳 Wuxi, Jiangsu, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Ditan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China

Hangzhou Choutu Technology Co.,Ltd.; 🇨🇳 Hangzhou, Zhejiang, China