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This dose-escalating study is to evaluate the efficacy and the safety of different doses 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(IFN) by exploring the dose-effect relationship, while identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method is adopted to assess the pharmacokinetic behavior, individuals / intra-individual variability, and the possible factors for further study.
Total 200 subjects will be randomized and enrolled into four groups proportionally receiving experimental drug of high dose, middle dose, low dose and positive-control drug. Treatment duration will be 24 or 48 weeks corresponding to different HCV genotype, genotype 2,3 and non-genotype2,3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (PEG-IFN-SA /RBV low dose) | Experimental | PEG-IFN-SA 0.75μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),(BW<75kg,1000mg/d;BW≥75kg,1200mg/d) |
|
| B (PEG-IFN-SA /RBV middle dose) | 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) |
|
| C (PEG-IFN-SA /RBV high dose) | Experimental | PEG-IFN-SA 2.0μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),(BW<75kg,1000mg/d;BW≥75kg,1200mg/d) |
|
| D (Pegasys /RBV) | Active Comparator | Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),(BW<75kg,1000mg/d;BW≥75kg,1200mg/d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-IFN-SA /RBV low dose | Drug | 24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| cEVR (complete early virologic response) | defined as the proportion of patients who had undetectable plasma HCV RNA at weeks 12 | weeks 12 of study therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who had undetectable plasma HCV RNA | weeks 4, 24, 48 of study therapy and 24 weeks after the end of treatment | |
| HCV RNA load reduction | weeks 4, 12, 24, 48 of study therapy and 24 weeks after the end of treatment |
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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 |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China | |||
| First Affiliated Hospital of Lanzhou University |
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| PEG-IFN-SA /RBV middle dose | Drug | 24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3 |
|
| PEG-IFN-SA /RBV high dose | Drug | 24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3 |
|
| Pegasys /RBV | Drug | 24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3 |
|
| eRVR ( extended rapid virologic response) | defined as the proportion of patients who had undetectable plasma HCV RNA at weeks 4 and 12 | weeks 4 and 12 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 24, 48 of study therapy |
| Relapse | defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after then | 12 and 24 weeks after the end of treatment |
| Lanzhou |
| Gansu |
| China |
| Guangdong General Hospital | Guangzhou | Guangdong | China |
| Guangzhou Eighth People's Hospital | Guangzhou | Guangdong | China |
| Nanfang Hospital Southern Medical Unbiversity | Guangzhou | Guangdong | China |
| The third people's hospital of Shenzhen | Shenzhen | Guangdong | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | China |
| Third Affiliated Hospital, Hebei Medical University | Shijiazhuang | Hebei | China |
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | China |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | 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 |
| The first affiliated hospital of suzhou university | Suzhou | 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 |
| Shandong Provincial Hospital | 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 |
| Xixi Hospital of Hangzhou | Hangzhou | Zhejiang | 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 Union Medical College Hospital | Beijing | China |
| Peking University First Hospital | Beijing | China |
| Peking University People's Hospital | Beijing | China |
| Chongqing Southwest Hospital | Chongqing | China |
| Daping Hospital, Research Institute of Surgery Third Military Medical University | Chongqing | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| Ruijing Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | 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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