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Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients | Clinical Trials | Clareo Health

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Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

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

NCT03777969•Beijing Friendship Hospital

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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;
+1 more criteria

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
•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;
+5 more criteria

Locations (7)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Wuxi Hisky Medical Technologies Co., Ltd.

Wuxi, Jiangsu, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Hangzhou Choutu Technology Co.,Ltd.

Hangzhou, Zhejiang, China

Key Dates

Start Date

June 29, 2018

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2028

Last Updated

September 6, 2022

Enrollment

2,000

ESTIMATED participants

Conditions

Chronic Hepatitis b

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

Inclusion Criteria

Exclusion Criteria

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