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At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin | Experimental |
| |
| Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin | Experimental |
| |
| Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-791325 | Drug | Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Formal analysis at week 4 (and upon occurrence) | |
| Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Formal analysis at week 12 (and upon occurrence) | |
| Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Formal analysis at week 24 post treatment (and upon occurrence) | |
| Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Formal analysis at week 48 post treatment (and upon occurrence) | |
| Antiviral activity, as determined by the proportion subjects with eRVR | Week 4 | |
| Antiviral activity, as determined by the proportion subjects with eRVR | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV 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 |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States | ||
| Loyola University Medical Center |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C587012 | 8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| BMS-791325 | Drug | Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response |
|
| Placebo | Drug | Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response |
|
| Peg-interferon alfa-2a | Drug | Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response |
|
|
| Ribavirin | Drug | Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response |
|
|
| Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up | Week 12 |
| Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up | Week 24 |
| Resistant HCV variants associated with virologic failure | End of treatment (Week 48) or upon early discontinuation |
| Maywood |
| Illinois |
| 60153 |
| United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Digestive Disease Associates, P.A. | Baltimore | Maryland | 21229 | United States |
| Claudia T. Martorell, Md, Llc | Springfield | Massachusetts | 01107 | United States |
| Charlotte Gastroenterology & Hepatology, Pllc | Charlotte | North Carolina | 28207 | United States |
| Options Health Research, Llc | Tulsa | Oklahoma | 74104 | United States |
| The North Texas Research Institute | Arlington | Texas | 76012 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |