Clinical trial NCT03777969: Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients
Official title: Precise Prediction System for Clinical Endpoint Events of Chronic Hepatitis B Patients in the Ear of Antiviral Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Hepatitis b
Keywords: Chronic Hepatitis B
Liver fibrosis/cirrhosis
HBV-related endpoint events
Precise prediction model
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Ruijin Hospital
name: ShuGuang Hospital
name: Beijing Ditan Hospital
name: Hangzhou Choutu Technology Co.,Ltd.
name: Wuxi Hisky Medical Technologies Co., Ltd.
First posted: 2018-12-19
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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 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 criteria: 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.

Primary outcomes:
measure: HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death
timeFrame: 1 to 10 years
Secondary outcomes:
measure: Predicted probability of HBV-related clinical endpoint events
timeFrame: 1 to 10 years
measure: Predicted probability of HBV-induced fibrosis/cirrhosis regression
timeFrame: 1 to 10 years
measure: Percentage of HBV-induced liver fibrosis/cirrhosis regression
timeFrame: 1 to 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Wuxi
country: China
facility: Wuxi Hisky Medical Technologies Co., Ltd.
state: Jiangsu
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Hangzhou Choutu Technology Co.,Ltd.
state: Zhejiang
Study officials:
affiliation: Beijing Friendship Hospital
name: Hong You, Doctor
role: PRINCIPAL_INVESTIGATOR
References: