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The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBeAg positive group | Other | Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . |
|
| HBeAg-negative group | Other | Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir maleate tablets | Drug |
| ||
| blank Baraclude tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Compared with baseline, decline of serum HBV-DNA in the value | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu Yan yan, doctor | Department of Infectious Diseases,Peking University First Hospital | Principal Investigator |
| Shi Guang feng, doctor | Huashan Hospital | Principal Investigator |
| Xie Qing, doctor | Shanghai Jiaotong University Affiliated Ruijin Hospital | Principal Investigator |
| Tang Hong, doctor | West China Hospital | Principal Investigator |
| Zhang Da zhi, doctor | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Mao Qing, doctor | The First Affiliated Hospital Of The Third Mililary Medical University | Principal Investigator |
| Ning Qin, doctor | Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology | Principal Investigator |
| Li Jun, doctor | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Sheng Ji fang, doctor | Zhejiang University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases,Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36246814 | Derived | Xu JH, Wang S, Zhang DZ, Yu YY, Si CW, Zeng Z, Xu ZN, Li J, Mao Q, Tang H, Sheng JF, Chen XY, Ning Q, Shi GF, Xie Q, Zhang XQ, Dai J. One hundred and ninety-two weeks treatment of entecavir maleate for Chinese chronic hepatitis B predominantly genotyped B or C. World J Clin Cases. 2022 Oct 6;10(28):10085-10096. doi: 10.12998/wjcc.v10.i28.10085. | |
| 28345157 |
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| Drug |
|
| Blank maleate entecavir tablets | Drug |
|
| Baraclude tablets | Drug |
|
| Principal Investigator |
| Cheng Xin fang, doctor | Beijing You An Hospital,Capital Medical University | Principal Investigator |
| Beijing You An Hospital,Capital Medical University |
| Beijing |
| Beijing Municipality |
| 100054 |
| China |
| The First Affiliated Hospital Of The Third Mililary Medical University | Chongqing | Chongqing Municipality | 400038 | China |
| Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| The First Affiliated Hospital Of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| Shanghai Jiaotong University Affiliated Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
| The Second Affiliated Hospital Of Chongqing Medical University | Chongqing | Sichuan | 400010 | China |
| West China Hospital Of Sichuan University | Chongqing | Sichuan | 400010 | China |
| The First Affiliated Hospital Of Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Xu JH, Wang S, Xu ZN, Yu YY, Si CW, Zeng Z, Li J, Mao Q, Zhang DZ, Tang H, Sheng JF, Chen XY, Ning Q, Shi GF, Xie Q, Zhang XQ, Dai J. Entecavir maleate versus entecavir in Chinese chronic hepatitis B predominantly genotype B or C: Results at week 144. J Viral Hepat. 2017 Oct;24(10):877-884. doi: 10.1111/jvh.12710. Epub 2017 Aug 11. |
| 26604649 | Derived | Li N, Xu JH, Yu M, Wang S, Si CW, Yu YY. Relationship between virological response and FIB-4 index in chronic hepatitis B patients with entecavir therapy. World J Gastroenterol. 2015 Nov 21;21(43):12421-9. doi: 10.3748/wjg.v21.i43.12421. |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C413685 | entecavir |
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