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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018702-36 | EudraCT Number |
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Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-824393 (10mg) | Experimental | Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
|
| BMS-824393 (30 mg) | Experimental | Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
|
| BMS-824393 (100 mg) | Experimental | Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
|
| Placebo | Placebo Comparator | Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
|
| Peginterferon alfa-2a plus Ribavirin | Other | Weeks 13 - 48 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-824393 | Drug | Capsule, Oral, 10 mg, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Week 4 | |
| Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Week 12 | |
| Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Week 24 | |
| Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Week 48 | |
| Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA | Week 4 | |
| Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA | Week 4 | |
| Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA | Week 12 |
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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 | Coronado | California | 92118 | United States | ||
| Research And Education, Inc. |
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| BMS-824393 |
| Drug |
Capsule, Oral, 30 mg, once daily |
|
| BMS-824393 | Drug | Capsule, Oral, 100 mg, once daily |
|
| Placebo | Drug | Capsule, Oral, 0 mg, once daily |
|
| Peginterferon Alpha-2a | Drug | Syringe, subcutaneous 180 mcg/0.5 mL, weekly |
|
|
| Ribavirin | Drug | Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily |
|
|
| Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable | Week 12 (SVR12) |
| Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable | Week 24 (SVR24) |
| Resistant variants associated with virologic failure | Week 4 |
| Resistant variants associated with virologic failure | Week 12 |
| Resistant variants associated with virologic failure | Follow up Week 12 |
| Resistant variants associated with virologic failure | Week 24 |
| San Diego |
| California |
| 92105 |
| United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Bach And Godofsky Infectious Diseases | Bradenton | Florida | 34209 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Vita Medical Center & Research Solutions, Inc. | Tamarac | Florida | 33319 | United States |
| Gastrointestinal Specialists Of Georgia Pc | Mareitta | Georgia | 30060 | United States |
| Maryland Digestive Disease Research | Laurel | Maryland | 20707 | United States |
| Local Institution | Philadelphia | Pennsylvania | 19141 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Liver Institute Of Virginia Bon Secours Health System | Newport News | Virginia | 23602 | United States |
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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