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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
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Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon alfa-2b injection, with nucleos(t)ide (NAs), tenofovir disoproxil fumarate tablets (TDF), in the patients with hepatitis B, who has previously treated with nucleos(t)ides and who are treatment naïve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nucleot(s)ide-treated patients-Experimental Group 1 | Experimental |
| |
| Nucleot(s)ide-treated patients-Experimental Group 2 | Experimental |
| |
| Nucleot(s)ide-treated patients-Control Group | Active Comparator |
| |
| Treatment Naive Group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b injection | Drug | Peginterferon alfa-2b injection (high dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HBsAg negative. | 24 weeks post treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of HBsAg level from baseline. | up to 168 weeks. | |
| Proportion of patients with HBsAg seroconversion. | up to 168 weeks. | |
| Proportion of patients with HBeAg negative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guiqiang Wang, Ph.D | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | China | ||||
| Beijing Youan Hospital, Capital Medical University |
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|
| Peginterferon alfa-2b injection | Drug | Peginterferon alfa-2b injection (low dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment. |
|
| TDF | Drug | Patients will take TDF orally for the first 48 weeks, and then one can choose to continue the single-TDF treatment up to 144 weeks, or may choose to change to receive peginterferon alfa-2b combined TDF therapy for the later 96 weeks, peginterferon alfa-2b will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 weeks a cycle. And then followed for 24 weeks after treatment. |
|
| Peginterferon alfa-2b injection | Drug | Peginterferon alfa-2b injection will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment. |
|
| up to 168 weeks |
| Proportion of patients with HBeAg seroconversion. | up to 168 weeks. |
| Changes of HBeAg level from baseline. | up to 168 weeks. |
| Proportion of patients with HBV DNA undetectable. | up to 168 weeks. |
| Changes of HBV DNA level from baseline. | up to 168 weeks. |
| Proportion of patients with ALT normalization. | up to 168 weeks. |
| Proportion of patients with liver fibrosis. | up to 168 weeks. |
| Proportion of patients with liver cirrhosis. | up to 168 weeks. |
| Beijing |
| China |
| Peking University First Hospital | Beijing | China |
| The fifth medical center of PLA General Hospital | Beijing | China |
| The Second Xiangya Hospital of Central South University | Changsha | China |
| Xiangya Hospital Central South University | Changsha | China |
| Public Health Clinical Center of Chengdu | Chengdu | China |
| Sichuan Provincial People's Hospital | Chengdu | China |
| Mengchao Hepatobiliary Hosipital of Fujian Medical University | Fuzhou | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | China |
| The Ninth Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army | Fuzhou | China |
| Guangzhou Eighth People's Hospital | Guangzhou | China |
| The Third Affiliated Hospital,SUN YAT-SEN University | Guangzhou | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | China |
| Nanjing Drum Tower Hospital/The First Affiliated Hospital of Nanjing University Medical School | Nanjing | China |
| Huashan Hospital affiliated to Fudan University | Shanghai | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China |
| The Sixth People's Hospital of Shenyang | Shenyang | China |
| Peiking University Shenzhen Hospital | Shenzhen | China |
| The Third People's Hospital of shenzhen | Shenzhen | China |
| The First Hospital of Shanxi Medical University | Taiyuan | China |
| First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | China |
| Tianjin Third Central Hospital | Tianjin | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | China |
| Traditional Chinese Medicine hospital of Xinjiang Uygur Autonomous Region | Ürümqi | China |
| Tongji Hospital/Tongji Medical College Huazhong University of Science & Technology | Wuhan | China |
| Tangdu Hospital | Xi'an | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | China |
| Xiamen Hospital of Traditional Chinese Medicine | Xiamen | China |
| Yanbian University Hospital/Yanbian Hospital | Yanbian | China |
| Henan Provincial People's Hospital | Zhengzhou | China |
| 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 |
|---|---|
| C417083 | peginterferon alfa-2b |
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