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The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Domestic Tenofovir Disoproxil Fumarate Tablets | Experimental |
| |
| Tenofovir Disoproxil Fumarate Tablets of Gilead | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domestic Tenofovir Disoproxil Fumarate Tablets | Drug | 1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compared with baseline, decline of serum HBV-DNA in the value | 48 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan yan Yu, doctor | Contact | 13901194223 | yyy@bjnu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yan yan Yu, doctor | Peking University First Hospital | Principal Investigator |
| Hao Wang, doctor | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100015 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34222435 | Derived | Chen XF, Fan YN, Si CW, Yu YY, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Xu JH. Tenofovir disoproxil fumarate in Chinese chronic hepatitis B patients: Results of a multicenter, double-blind, double-dummy, clinical trial at 96 weeks. World J Clin Cases. 2021 Jun 26;9(18):4690-4699. doi: 10.12998/wjcc.v9.i18.4690. | |
| 31415381 |
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| Tenofovir Disoproxil Fumarate Tablets of Gilead | Drug | 1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead |
|
| Jun Chen, doctor |
| Beijing Ditan Hospital |
| Principal Investigator |
| Xin yue Chen, doctor | Beijing You An Hospital, Capital Medical University | Principal Investigator |
| Wen hong Zhang, doctor | Huashan Hospital | Principal Investigator |
| Qing Xie, doctor | Ruijin Hospital | Principal Investigator |
| Shan ming Wu, doctor | Shanghai Public Health Clinical Center | Principal Investigator |
| Hong Tang, doctor | West China Hospital | Principal Investigator |
| Qing Mao, doctor | First Affiliated Hospital, Third Military Medical University | Principal Investigator |
| Zhi liang Gao, doctor | Third Affiliated Hospital of Sun Yat-sen | Principal Investigator |
| Ji fang Shen, doctor | Zhejiang University | Principal Investigator |
| Jun Li, doctor | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Wei Zhao, doctor | The Second Hospital of Nanjing Medical University | Principal Investigator |
| Jia Shang, doctor | Henan Provincial People's Hospital | Principal Investigator |
| Zu jiang Yu, doctor | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
|
| Beijing You An Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100069 | China |
|
| First Affiliated Hospital, Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400039 | China |
|
| Third Affiliated Hospital of Sun Yat-sen | Recruiting | Guangzhou | Guangdong | 510630 | China |
|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
|
| First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|
| The Second Hospital of Nanjing | Recruiting | Nanjing | Jiangsu | 210003 | China |
|
| First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
|
| Huashan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
|
| Shanghai Public Health Clinical Center | Recruiting | Shanghai | Shanghai Municipality | 201508 | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdou | Sichuan | 610041 | China |
|
| First Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| Derived |
| Liang RY, Xu JH, Si CW, Wang S, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Yu YY. A randomized, double-blind, double-dummy, controlled, multicenter study of Qingzhong (tenofovir disoproxil fumarate) versus Viread for the treatment of chronic hepatitis B: First-stage results at week 48. Medicine (Baltimore). 2019 Aug;98(33):e16778. doi: 10.1097/MD.0000000000016778. |
| 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 |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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