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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 Alfacon-2 injection, with nucleos(t)ide (NAs), Tenofovir alafenamide Fumarate Tablets (TAF), in the patients with hepatitis B virus infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon Alfacon-2 treated patients | Experimental |
| |
| Peginterferon Alfacon-2 placebo treated patients | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon Alfacon-2 | Drug | Peginterferon Alfacon-2 injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HBsAg negative. | Percentage of Participants with HBsAg <0.05 IU/mL | 72 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 Alfacon-2 placebo | Drug | Peginterferon Alfacon-2 placebo injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks. |
|
| Beijing |
| China |
| Peking university Peoole's hospital | Beijing | China |
| The First Hospital of Jilin University | Changchun | China |
| The second xiangya hospital of central south university | Changsha | China |
| Xiangya Hospital Central South University | Changsha | China |
| Sichuan Provincial People's Hospital | Chengdu | China |
| The Peoole's hospital of Chizhou | Chizhou | China |
| The First Affiliated Hospital of Army Medical University | Chongqing | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| Mengchao hepatobiliary hospital of Fujian medical university | Fuzhou | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | China |
| Guangzhou Eighth People's Hospital | Guangzhou | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | China |
| Heze Municipal Hospital | Heze | China |
| Shandong Public Health Clinical Center | Jinan | China |
| Hebei petro china central hospital | Langfang | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | China |
| The Second Hospital of Nanjing | Nanjing | China |
| Pingxiang NO.2 People's Hospital | Pingxiang | China |
| Qingdao Municipal Hospital | Qingdao | China |
| The Peoole's hospital of Qingyuan | Qingyuan | China |
| The Sixth People's Hospital of Shenyang | Shenyang | China |
| Shijiazhuang Hospital of Traditional Chinese Medicine | Shijiazhuang | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | China |
| The Second People's Hospital of Tianjin | Tianjin | China |
| Tianjin Third Central Hospital | Tianjin | China |
| Tongji medical college of Hust | Wuhan | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
| The Second Affiliated Hospital of Xian Jiaotong University | Xi'an | China |
| The third affiliated hospital of Xingxiang medical university | Xingxiang | China |
| Yanbian University Hospital | Yanbian | China |
| Henan People's Hospital | Zhengzhou | China |
| The Sixth People's Hospital of Zhengzhou | 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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