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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002519-24 | EudraCT Number |
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The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo | Experimental | Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 1 to Arm 1a and 1b (additional 12 weeks treatment) |
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| Arm 2: Daclasasvir + BMS-986094 (200 mg) | Experimental | Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 2 to Arm 2a and 2b (additional 12 weeks treatment) |
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| Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin | Experimental | Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment) |
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| Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin | Experimental | Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 4 to Arm 4a and 4b (additional 12 weeks treatment) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a) |
| Follow up Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treated subjects with SVR4 in genotype (GT) 1 naive and non-responder (NR) subjects randomized to the 24-week treatment arms (arms 1b, 2b, 3b, 4b) | Follow up Week 4 (SVR4) | |
| Proportion of treated subjects with SVR4 in genotype 1 protease inhibitor (PI)failures, genotype 4 naive, and genotype 2/3 NR/relapse subjects (arms 5, 6, 7) |
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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 | Orlando | Florida | 32804 | United States |
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| Arm 5: Daclasasvir + BMS-986094 (200 mg) | Experimental | Genotype 1 PI-failure subjects |
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| Arm 6: Daclasasvir + BMS-986094 (200 mg) | Experimental | Genotype 4 naive subjects |
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| Arm 7: Daclasasvir + BMS-986094 (200 mg) | Experimental | Genotype 2/3 NR/relapse Subjects |
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| Daclatasvir | Drug | Film coated tablet, Oral, 60 mg, Once daily, 24 weeks |
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| BMS-986094 | Drug | Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks |
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| BMS-986094 | Drug | Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks |
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| BMS-986094 | Drug | Capsule, Oral, 200 mg, Once daily, 24 Weeks |
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| Ribavirin | Drug | Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks |
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| Placebo for BMS-986094 | Drug | Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks |
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| Follow up Week 4 (SVR4) |
| Proportion of treated subjects in each study population (GT1 naive, GT1 NR, or GT1 PI-failure, GT4 naive, GT2/3 NR/relapse), for each regimen and duration, who achieve HCV RNA < LOQ at post-treatment | Post-treatment Week 2 (SVR2), Week 8 (SVR8), Week 12 (SVR12), Week 24 (SVR24), and Week 36 (SVR36, for the 12 week arms) |
| Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable) | Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24) |
| Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable | Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24) |
| Safety and tolerability of BMS-986094 and DCV ± RBV as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), and severity Grade 3/4 laboratory abnormalities | Up to post treatment Week 36 |
| 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 |
| C553340 | BMS-986094 |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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