Status:
ACTIVE_NOT_RECRUITING
Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients
Lead Sponsor:
Beijing Friendship Hospital
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Ruijin Hospital
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
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 ...
Detailed Description
No.
Eligibility Criteria
Inclusion
- Group 1: Patients with history of HBV-related clinical endpoint events
- 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
- 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.
Key Trial Info
Start Date :
June 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT03777969
Start Date
June 29 2018
End Date
December 31 2028
Last Update
September 6 2022
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100015
2
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
3
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
4
Wuxi Hisky Medical Technologies Co., Ltd.
Wuxi, Jiangsu, China