Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients
NCT03777969 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000
Last updated 2022-09-06
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.
Conditions
Sponsors & Collaborators
-
Nanfang Hospital, Southern Medical University
collaborator OTHER -
Ruijin Hospital
collaborator OTHER -
ShuGuang Hospital
collaborator OTHER -
Beijing Ditan Hospital
collaborator OTHER -
Hangzhou Choutu Technology Co.,Ltd.
collaborator UNKNOWN -
Wuxi Hisky Medical Technologies Co., Ltd.
collaborator UNKNOWN -
Beijing Friendship Hospital
lead OTHER
Principal Investigators
-
Hong You, Doctor · Beijing Friendship Hospital
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-29
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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