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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
| Ruijin Hospital | OTHER |
| ShuGuang Hospital | OTHER |
| Beijing Ditan Hospital |
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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.
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| 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 | Incidence of HBV-related clinical endpoint events during follow-ups | 1 to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Predicted probability of HBV-related clinical endpoint events | 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 |
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Group 1: Patients with history of HBV-related clinical endpoint events
Inclusion Criteria:
Exclusion Criteria:
Group 2: Patients without history of clinical endpoint events
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hong You, Doctor | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Beijing Friendship Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38040276 | Derived | Sun Y, Chen W, Chen S, Wu X, Zhang X, Zhang L, Zhao H, Xu M, Chen Y, Piao H, Li P, Li L, Jiang W, Li X, Xing H, Liu X, Zhang Y, Wang B, Zhou J, Meng T, Zhao X, Shao C, Kong Y, Zhao X, Ou X, Liu C, Jia J, You H. Regression of Liver Fibrosis in Patients on Hepatitis B Therapy Is Associated With Decreased Liver-Related Events. Clin Gastroenterol Hepatol. 2024 Mar;22(3):591-601.e3. doi: 10.1016/j.cgh.2023.11.017. Epub 2023 Nov 30. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| OTHER |
| Hangzhou Choutu Technology Co.,Ltd. | UNKNOWN |
| Wuxi Hisky Medical Technologies Co., Ltd. | UNKNOWN |
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Liver biopsy and peripheral blood
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 | 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 |
| Beijing |
| Beijing Municipality |
| China |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | 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 |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |