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This study is to confirm the potential effects and assess the safety of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin(RBV) in the treatment of Chronic hepatitis C who have not been previously treated with Interferon.
Total 720 subjects are divided into two groups and treated separately according to the HCV genotype(genotype 2,3 and non-genotype 2,3). With 2:1 ratio between experimental group and positive-control group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype 2,3 and 504 subjects for non-genotype2,3 will be enrolled. Accordingly, PEG-IFN-SA once weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV genotype 2,3 and the HCV non-genotype 2,3 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-IFN-SA /RBV T1(Genotype2,3) | Experimental | PEG-IFN-SA/RBV, 1.5μg/kg/week im and RBV 1000mg-1200mg/d po bid(BW<75kg,1000mg/d; BW≥75kg, 1200mg/d),24 weeks |
|
| Pegasys /RBV C1(Genotype 2,3) | Active Comparator | Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),(BW<75kg,1000mg/d;BW≥75kg,1200mg/d)for 24 weeks |
|
| PEG-IFN-SA /RBV T2(Non-genotype 2,3) | Experimental | PEG-IFN-SA 1.5μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),(BW<75kg,1000mg/d;BW≥75kg,1200mg/d)for 48 weeks |
|
| Pegasys /RBV C2(Non-genotype 2,3) | Active Comparator | Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),(BW<75kg,1000mg/d;BW≥75kg,1200mg/d)for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-IFN-SA /RBV | Drug |
| ||
| Pegasys /RBV |
| Measure | Description | Time Frame |
|---|---|---|
| SVR (sustained virologic response) | defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of SVR (sustained virologic response) defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of treatment | 24 weeks after 24 or 48 weeks of study therapy |
| Measure | Description | Time Frame |
|---|---|---|
| RVR(rapid virologic response) | defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4 | weeks 4 of study therapy |
| cEVR (complete early virologic response) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheng jun, MD, PhD | Beijing Ditan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Lanzhou University | Lanzhou | Gansu | China | |||
| Guangzhou Eighth People's Hospital |
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| Drug |
|
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 12
| weeks 12 of study therapy |
| ETVR( end of treatment virologic response) | defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at the end of treatment | weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3 |
| eRVR ( extended rapid virologic response) | defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4 and 12 | weeks 4 and 12 of study therapy |
| No-responses | defined as the proportion of patients who had less than a <2 log IU/ml plasma HCV RNA decline at weeks 12 or had detectable plasma HCV RNA at weeks 24 | weeks 12 or weeks 24 of study therapy |
| Breakthrough | defined as the proportion of patients who had detectable plasma HCV RNA at any point during treatment after virological response( undetectable plasma HCV RNA) | weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3 |
| Relapse | defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after the then | 12 and 24 weeks after 24 or 48 weeks of study therapy |
| Guangzhou |
| Guangdong |
| China |
| Nanfang Hospital Southern Medical Unbiversity | Guangzhou | Guangdong | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | China |
| Third Affiliated Hospital, Hebei Medical University | Shijiazhuang | Hebei | China |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | China |
| Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology | Wuhan | Hubei | China |
| Union hospital, Tongji Medical College Huazhong University of Science & Technology | Wuhan | Hubei | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Xiangya Hospital Central-South University | Changsha | Hunan | China |
| Jiangsu province hospital | Nanjing | Jiangsu | China |
| The Second Hospital of Nanjing | Nanjing | Jiangsu | China |
| First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| The First Affiliated Hospital of Jilin University | Changchun | Jilin | China |
| Yanbian University Hospital (Yanbian Hospital) | Yanji | Jilin | China |
| The Sixth People's Hospital of Shenyang | Shenyang | Liaoning | China |
| First Affiliated Hospital Of Medical College of Xian Jiaotong University | Xi'an | Shaanxi | China |
| Second Affiliated Hospital Of Medical College of Xian Jiaotong University | Xi'an | Shaanxi | China |
| Tangdu Hospital,Fourth Military Medical University | Xi'an | Shaanxi | China |
| Jinan Infectious Disease Hospital | Jinan | Shandong | China |
| Qilu Hospital of Shandong university | Jinan | Shandong | China |
| Qingdao Municipal Hospital | Qingdao | Shandong | China |
| The First Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| Sichuan Academy of Medical Science &Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | China |
| The First Teaching Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| 302 Military Hospital of China | Beijing | China |
| Beijing Ditan Hospital, Capital Medical University | Beijing | China |
| Beijing Youan Hospital, Capital Medical University | Beijing | China |
| Beijing Youyi Hospital, capital Medical University | Beijing | China |
| General Hospital of Beijing Military Region | Beijing | China |
| Peking University First Hospital | Beijing | China |
| Peking University People's Hospital | Beijing | China |
| Chongqing Southwest Hospital | Chongqing | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| Shanghai Public Health Clinical Center | Shanghai | China |
| Tianjin Infectious Disease Hospital | Tianjin | 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 |
|---|---|
| C571406 | PEG-IFN-SA |
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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