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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
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This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week & Ribavirin as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d |
|
| Group 2 | Experimental | Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d |
|
| Group 3 | Experimental | Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d |
|
| Group 4 | Active Comparator | Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ypeginterferon alfa-2b | Drug | sc, qw, for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Proportion of patients with HCV RNA undetectable at week 12. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy |
| Week 4, 12, 24, 48 and 72 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Lai, MD, PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 302 Military Hospital | Beijing | China | ||||
| Beijing Youan Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24625322 | Derived | Feng B, Yang RF, Xie Q, Shang J, Kong FY, Zhang HY, Rao HY, Jin Q, Cong X, Liu YY, Kang Y, Wei L. Hepatitis C virus core antigen, an earlier and stronger predictor on sustained virological response in patients with genotype 1 HCV infection. BMC Gastroenterol. 2014 Mar 13;14:47. doi: 10.1186/1471-230X-14-47. |
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| Peginterferon alfa-2a | Drug | sc, qw, for 48 weeks. |
|
|
| Beijing |
| China |
| Beijing Youyi Hospital, Capital Medical University | Beijing | China |
| Peking University First Hospital | Beijing | China |
| Peking University People's Hospital | Beijing | China |
| First Affiliated Hospital of Jilin University | Changchun | China |
| Xiangya Hospital, Central-south University | Changsha | China |
| Xiangya Second Hospital, Central-south University | Changsha | China |
| West China Hospital, Sichuan University | Chengdu | China |
| Second Affiliated Hospital Chongqing Medical University | Chongqing | China |
| Southwest Hospital | Chongqing | China |
| Fuzhou Infectious Disease Hospital | Fuzhou | China |
| Guangzhou Eighth People's Hospital | Guangzhou | China |
| Nangfang Hospital | Guangzhou | China |
| First Affiliated Hospital of Guangxi Medical Universtiy | Guilin | China |
| Second Affiliated Hospital of Harbin Medical University | Harbin | China |
| First Affiliated Hospital of Anhui Medical University | Hefei | China |
| Jinan Infectious Disease Hospital | Jinan | China |
| First Affiliated Hospital of Lanzhou University | Lanzhou | China |
| First Affiliated Hospital of Nanchang University | Nanchang | China |
| 81 Military Hospital | Nanjing | China |
| Jiangsu Province Hospital | Nanjing | China |
| Second Hospital of Nanjing | Nanjing | China |
| 85 Military Hospital | Shanghai | China |
| Changhai Hospital | Shanghai | China |
| Huashan Hospital | Shanghai | China |
| Renji Hospital | Shanghai | China |
| Ruijin Hospital | Shanghai | China |
| Shanghai Public Health Clinical Center | Shanghai | China |
| Shenzhen Third People's Hospital | Shenzhen | China |
| Third Affiliated Hospital, Hebei Medical University | Shijiazhuang | China |
| First Affiliated Hospital, Shanxi University | Taiyuan | China |
| Tianjin Third Central Hospital | Tianjin | China |
| First Affiliated Hospital of Wenzhou Medical College | Wenzhou | China |
| Tongji Hospital, Huazhong University of Science&Technology | Wuhan | China |
| Tangdu Hospital, Fouth Military Medical University | Xi'an | China |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
| Henan Provincial People's Hospital | Zhengzhou | China |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D008107 | Liver Diseases |
| D006521 | Hepatitis, Chronic |
| D006525 | Hepatitis, Viral, Human |
| D018347 | Hepadnaviridae Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| C100416 | peginterferon alfa-2a |
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