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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03777969
Other study ID # 2018ZX10302204-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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