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The aim of our study is to validate the non-invasive model which was constructed by our previous study for evaluating liver fibrosis or cirrhosis caused by hepatitis B virus in mainland China and to find a therapeutic regimen to reverse liver fibrosis and cirrhosis.
450 patients who are infected with hepatitis B virus for at least 6 months will be included in the study. They will be divided into two groups. One group will be treated with Entecavir while another treated with Entecavir and Anluohuaxian Pill. Liver biopsy samples and blood samples from the patients will be used to validate the non-invasive model. Furthermore, the samples will be used to evaluate if Anluohuaxian Pill could reverse liver fibrosis and cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir Group | Active Comparator | Patients in this arm will be given Entecavir 0.5 mg a day for 2 years. |
|
| Entecavir and Anluohuaxian Group | Experimental | Patients in this arm will be given Entecavir 0.5 mg and Anluohuaxian Pill 12 g a day for 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir 0.5 mg | Drug | Patients in this group will be given Entecavir 0.5 mg a day for 2 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Construct a non-invasive model based on laboratory tests | We will measure the following biomarkers: TIMP1,CXCL10,CD25,YKL-40,collagen IV,von Willebrand Factor,TGF-β1,ANGPTL2,MMP-9,IL-2R,PDGF-AA,PDGF-BB,TGF-a,LN,MMP-1, soluble CD163 and CXCL9. To formulate the predictive models for detecting significant fibrosis (Ishak fibrosis score ≥3), univariate analysis was performed on variables between patients with and without significant fibrosis. The significant variables (p<0.05) were then subjected to multivariate stepwise logistic regression, using backward approaches, and were combined using the logistic regression function. The diagnostic value of each regression model was assessed using receiver operating characteristics curves. | 26 weeks after liver biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the difference of fibrosis reverse rates between the two groups | Liver biopsy samples will be evaluated by Ishak fibrosis score. Then we compare the difference of fibrosis reverse rates between the two groups by Ishak fibrosis score. | 26 weeks after liver biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guiqiang Wang | Contact | 13911405123 | john131212@126.com | |
| Hong Zhao | Contact | 13810765943 | minmin2001@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Guiqiang Wang | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guiqiang Wang | Recruiting | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37396307 | Derived | Li J, Dong XQ, Cao LH, Zhang ZQ, Zhao WF, Shang QH, Zhang DZ, Ma AL, Xie Q, Gui HL, Zhang G, Liu YX, Shang J, Xie SB, Liu YQ, Zhang C, Wang GQ, Zhao H; China HepB Related Fibrosis Assessment Research Group. Factors associated with persistent positive in HBV DNA level in patients with chronic Hepatitis B receiving entecavir treatment. Front Cell Infect Microbiol. 2023 Jun 16;13:1151899. doi: 10.3389/fcimb.2023.1151899. eCollection 2023. |
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| Anluohuaxian Pill 12g | Drug | Patients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years |
|
|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
|
| Beijing Youan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
|
| Beijing Youan Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| Beijing Youan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Peking University First hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
|
| Nanfang Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| The People's Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | Guangxi | China |
|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | China |
|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
|
| Wuxi the Fifth People's Hospital | Recruiting | Wuxi | Jiangsu | China |
|
| Shanghai Public Health Clinical Center | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanghai Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | China |
|
| Zhejiang First Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| C000708108 | anluohuaxian |
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