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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01265511 | Study of SCY-635, Pegasys and Copegus in Hepatitis C | PHASE2 | COMPLETED | 10 | — | — | Nov 1, 2010 | Oct 1, 2011 | Aug 18, 2017 | 4 | United States, Puerto Rico |
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks |
| SCY-635 600 mg | ACTIVE_COMPARATOR | SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Oral tablets given bid for 28 days |
| SCY-635 | DRUG | SCY-635 tablets, 300 mg bid for 28 days |
| Pegasys | DRUG | 180 ug prefilled syringe given once per week for up to 48 weeks |
| Copegus | DRUG | tablets given bid for up to 48 weeks |
Inclusion Criteria: * Quantifiable serum levels of HCV-specific RNA in excess of 100,000 IU/mL * Chronic HCV status * HCV genotype 1 infection and IL28B genotype of C/T or T/T * Liver biopsy results within 3 years prior to screening indicating the absence of cirrhosis \*If no previous biopsy is ...