Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01497834 | A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients | PHASE3 | COMPLETED | 224 | — | — | Jan 1, 2012 | Jun 1, 2013 | Oct 9, 2015 | 24 | Japan |
| NCT01448044 | Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C | PHASE3 | COMPLETED | 152 | — | — | Dec 1, 2011 | Jan 1, 2014 | Oct 12, 2015 | 26 | United States, France +5 |
SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)
Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels \< lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.
| Arm | Type | Description |
|---|---|---|
| Daclatasvir + Asunaprevir | EXPERIMENTAL | - |
| BMS-790052 + PegIFNα-2a + Ribavirin | EXPERIMENTAL | * BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks * PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response * Ribavirin 400 mg (2 tablets for participants \< 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response |
| Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin | PLACEBO_COMPARATOR | * Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks * PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks * Ribavirin 400 mg (2 tablets for participants \< 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks |
| Name | Type | Description |
|---|---|---|
| BMS-790052 (Daclatasvir) | DRUG | Tablets, Oral, 60mg, Once daily, 24 weeks |
| BMS-650032 (Asunaprevir) | DRUG | Capsules, Oral, 100mg, Twice daily, 24 weeks |
| BMS-790052 (NS5A Replication Complex Inhibitor) | DRUG | - |
| Placebo matching BMS-790052 | DRUG | - |
| Pegylated-interferon alfa 2a | DRUG | - |
| Ribavirin | DRUG | - |
Inclusion Criteria: * Chronic HCV-1b infected patient * HCV RNA viral load of ≥ 100,000 IU/mL at screening * Ages 20 to 75 years * Non-responder to Interferon plus Ribavirin therapy * Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy Exc...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | — | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | — | Undisclosed |