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The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active dual arm | Active Comparator | Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 24 week and follow up to week 48 |
|
| Placebo arm | Placebo Comparator | Daclatasvir placebo in tablet form QD and Asunaprevir placebo in soft capsule form BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 36 week and follow up to week 60 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Daclatasvir tablet 60mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12) | HCV RNA < Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 | Post-treatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with anemia on active Dual therapy | Post-treatment Week 12 | |
| Proportion of subjects with neutropenia on active Dual therapy | Post-treatment Week 12 | |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Beijing | Beijing Municipality | 100015 | China | ||
| Local Institution |
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| Asunaprevir |
| Drug |
Asunaprevir soft capsule 100 mg |
|
| Proportion of subjects with thrombocytopenia on active Dual therapy |
| Post-treatment Week 12 |
| On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Post-treatment week 12 |
| Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO) | first 12 weeks on treatment |
| Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO) | first 12 weeks on treatment |
| Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort | Post-treatment visit week 12 |
| Proportion of subjects with hepatitis C virus (HCV) RNA < LLOQ-TD/TND in each arm at various intervals after the initiation of active Dual therapy | post-treatment visit Week 24 |
| Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy | post-treatment visit Week 24 |
| Proportion of treated subjects with SVR12 for subjects randomized to placebo | Post-treatment visit week 12 |
| Beijing |
| Beijing Municipality |
| 100034 |
| China |
| Local Institution | Beijing | Beijing Municipality | 100050 | China |
| Local Institution | Beijing | Beijing Municipality | 100054 | China |
| Local Institution | Guangzhou | Guangdong | 510060 | China |
| Local Institution | Guangzhou | Guangdong | 510515 | China |
| Local Institution | Shijiazhuang | Hebei | 050051 | China |
| Local Institution | Changsha | Hunan | 410008 | China |
| Local Institution | Nanjing | Jiangsu | 210002 | China |
| Local Institution | Nanjing | Jiangsu | 210003 | China |
| Local Institution | Nanjing | Jiangsu | 210029 | China |
| Local Institution | Zhenjiang | Jiangsu | 212000 | China |
| Local Institution | Changchun | Jilin | 130021 | China |
| Local Institution | Shenyang | Liaoning | 110002 | China |
| Local Institution | Shenyang | Liaoning | 110006 | China |
| Local Institution | Qingdao | Shandong | 266011 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200025 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200062 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200083 | China |
| Local Institution | Xi’an | Shanxi | 710038 | China |
| Local Institution | Xi’an | Shanxi | 710061 | China |
| Local Institution | Chengdu | Sichuan | 610041 | China |
| Local Institution | Beijing | 100039 | China |
| Local Institution | Moscow | 127015 | Russia |
| Local Institution | Saint Petersburg | 190103 | Russia |
| Local Institution | Saint Petersburg | 191167 | Russia |
| Local Institution | Busan | 47392 | South Korea |
| Local Institution | Seoul | 07061 | South Korea |
| Local Institution | Seoul | 08308 | South Korea |
| 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 |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
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