Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

Chronic Hepatitis b Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03777969
• Other study ID #: 2018ZX10302204-001
• Status: Active, not recruiting
• Start date: June 29, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: September 2022
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

No.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
China	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Hangzhou Choutu Technology Co.,Ltd.	Hangzhou	Zhejiang
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	Wuxi Hisky Medical Technologies Co., Ltd.	Wuxi	Jiangsu

Sponsors (7)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Ditan Hospital, Hangzhou Choutu Technology Co.,Ltd., Nanfang Hospital of Southern Medical University, Ruijin Hospital, ShuGuang Hospital, Wuxi Hisky Medical Technologies Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death	Incidence of HBV-related clinical endpoint events during follow-ups	1 to 10 years
Secondary	Predicted probability of HBV-related clinical endpoint events	The predicted probability is measured by histological prediction model or non-invasive prediction model	1 to 10 years
Secondary	Predicted probability of HBV-induced fibrosis/cirrhosis regression	The predicted probability is measured by histological prediction model or non-invasive prediction model	1 to 10 years
Secondary	Percentage of HBV-induced liver fibrosis/cirrhosis regression	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