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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01741545 | Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia | PHASE3 | COMPLETED | 71 | — | — | Mar 31, 2013 | Jan 31, 2015 | Aug 11, 2020 | 32 | United States, Australia +6 |
SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
| Arm | Type | Description |
|---|---|---|
| Cohort A: Genotype-2,-3 (Lambda/RBV/DCV) | EXPERIMENTAL | Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks |
| Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV) | EXPERIMENTAL | Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Pegylated-Interferon-lambda | BIOLOGICAL | - |
| Ribavirin | DRUG | - |
| Daclatasvir | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Severe hemophilia (defined as \< 1% factor activity level) * Infection with the hepatitis C virus (HCV) with underlying hemophilia * Males 18 years of age and above * Have n...