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The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1(Genotype2/3) | Experimental | Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day |
|
| A2(Genotype 2/3) | Active Comparator | Pegasys 180μg/week, in combination with Ribavirin 800mg/day |
|
| B1(Non-genotype 2/3) | Experimental | Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight |
|
| B2(Non-genotype 2/3) | Active Comparator | Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ypeginterferon alfa-2b | Drug | sc, qw, 24 weeks. |
| |
| Pegasys |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy) | 24 weeks after the end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml) | at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3 |
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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 |
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| Drug |
sc, qw, 24 weeks. |
|
| Ypeginterferon alfa-2b | Drug | sc, qw, 48 weeks. |
|
| Pegasys | Drug | sc, qw, 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 |
| Nanfang Hospital | Guangzhou | China |
| Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | China |
| First Affiliated Hospital of Guangxi Medical University | Guilin | China |
| Affiliated Hospital of Guiyang Medical College | Guiyang | China |
| First Affiliated Hospital, Zhejiang University | Hangzhou | 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 Militay Hospital | Shanghai | China |
| Huashan Hospital | Shanghai | China |
| Renji Hospital | Shanghai | China |
| Ruijing Hospital | Shanghai | China |
| Shanghai Public Health Clinical Center | Shanghai | 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 Xinjiang Medical University | Ürümqi | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
| Tangdu Hospital, Fourth Military Medical University | Xi'an | China |
| Xijing Hospital | Xi'an | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | China |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
| Hennan Provincial People's Hospital | Zhengzhou | China |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| 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 |
|---|---|
| C100416 | peginterferon alfa-2a |
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