- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777969
Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients
September 2, 2022 updated by: Hong You, Beijing Friendship Hospital
Precise Prediction System for Clinical Endpoint Events of Chronic Hepatitis B Patients in the Ear of Antiviral Therapy
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
No.
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100015
- Beijing Ditan Hospital, Capital Medical University
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Beijing, Beijing, China
- Beijing Friendship Hospital, Capital Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Nanfang Hospital, Southern Medical University
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Jiangsu
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Wuxi, Jiangsu, China
- Wuxi Hisky Medical Technologies Co., Ltd.
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Shanghai
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Shanghai, Shanghai, China
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Shanghai, Shanghai, China
- Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
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Zhejiang
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Hangzhou, Zhejiang, China
- Hangzhou Choutu Technology Co.,Ltd.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
CHB patients with liver biopsy performed at least 1 year after antiviral therapy; or CHB patients with antiviral therapy for at least 1 year content to be performed liver biopsy at enrollment.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death
Time Frame: 1 to 10 years
|
Incidence of HBV-related clinical endpoint events during follow-ups
|
1 to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predicted probability of HBV-related clinical endpoint events
Time Frame: 1 to 10 years
|
The predicted probability is measured by histological prediction model or non-invasive prediction model
|
1 to 10 years
|
Predicted probability of HBV-induced fibrosis/cirrhosis regression
Time Frame: 1 to 10 years
|
The predicted probability is measured by histological prediction model or non-invasive prediction model
|
1 to 10 years
|
Percentage of HBV-induced liver fibrosis/cirrhosis regression
Time Frame: 1 to 10 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 29, 2018
Primary Completion (ANTICIPATED)
December 31, 2028
Study Completion (ANTICIPATED)
December 31, 2028
Study Registration Dates
First Submitted
October 27, 2018
First Submitted That Met QC Criteria
December 13, 2018
First Posted (ACTUAL)
December 19, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 6, 2022
Last Update Submitted That Met QC Criteria
September 2, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
Other Study ID Numbers
- 2018ZX10302204-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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