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This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir administered for 12 weeks in patients with Hepatitis C (HCV) genotype1. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seraprevir and sofosbuvir | Experimental | Subjects will receive oral tablets of Seraprevir 100mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seraprevir | Drug | Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12） | SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 15 IU/mL) 12 weeks following the last dose of study drug. | Posttreatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4) | SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug. | Posttreatment Week 4 |
| Percentage of Participants Achieving a On-treatment Virologic Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuegang Wu | Ginkgo Pharma Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital,Capital Medical University | Beijing | Beijing Municipality | China | |||
| Beijing Friendship Hospital,Capital Medical University |
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| Sofosbuvir | Drug | Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12 |
|
|
Percentage of participants who achieved HCV RNA \ |
| week 1,week 2,week 4,week8,week 12 |
| Beijing |
| Beijing Municipality |
| China |
| Beijing YouAn Hospital ,Capital Medical University | Beijing | Beijing Municipality | China |
| Chongqing Public Health Medical Center | Chongqing | Chongqing Municipality | China |
| Chongqing Sanxia Center Hospital | Chongqing | Chongqing Municipality | China |
| Liuzhou General Hospital | Liuzhou | Guangxi | China |
| Affiliated Hospital Of Zunyi Medical University | Zunyi | Guizhou | China |
| The First Hospital Of Hebei Medical University | Shijiazhuang | Hebei | China |
| The Sixth People's Hospital Of Zhengzhou | Zhengzhou | Henan | China |
| Tongji Hospital Affiliated To Tongji Medical College Huazhong University Of Science And technology | Wuhan | Hubei | China |
| Wuhan Medical Treatment Center | Wuhan | Hubei | China |
| Wuxi No.5 People's Hospital | Wuxi | Jiangsu | China |
| The Affiliated Hospital OF Xuzhou Medical University | Xuzhou | Jiangsu | China |
| The first hospital of JILIN university. | Changchun | Jilin | 130000 | China |
| The First Affiliated Hospital Of Guangxi Medical University | Guangxi | Nanning | China |
| First Hospital Of Shanxi Medical University | Taiyuan | Shanxi | China |
| Traditional Chinese Medical Hospital Affiliated To Southwest Medical University | Luzhou | Sichaun | China |
| Chengdu Public Health Medical Center | Chengdu | Sichuan | China |
| Sichuan Province General Hospital | Chengdu | Sichuan | China |
| First Affiliated Hospital Of Xinjiang Medical University | Ürümqi | Xinjiang | China |
| Traditional Chinese Medical Hospital Uygur Autonomous Region | Ürümqi | Xinjiang | China |
| Huzhou Center Hospital | Huzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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