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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01225380 | A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C | PHASE2 | COMPLETED | 324 | — | — | Oct 1, 2010 | Sep 1, 2013 | Jan 28, 2014 | 114 | United States, Austria +9 |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | GS-9190 and GS-9256 in combination with Pegasys® and Copegus® for 16 or 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy |
| Arm 2 | EXPERIMENTAL | GS-9256 (active) and placebo matching GS-9190 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy |
| Arm 3 | PLACEBO_COMPARATOR | Placebo matching GS-9190 and placebo matching GS-9256 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration |
| Name | Type | Description |
|---|---|---|
| GS-9190 | DRUG | GS-9190 capsule, 20 mg BID, 16 or 24 weeks |
| GS-9256 | DRUG | GS-9256 capsule, 150 mg BID, 16 or 24 weeks |
| Pegasys® | BIOLOGICAL | peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks |
| Copegus® | DRUG | ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks |
| GS-9190 placebo | DRUG | placebo matching GS-9190 capsule BID, 24 weeks |
| GS-9256 placebo | DRUG | placebo matching GS-9256 capsule BID, 24 weeks |
Inclusion Criteria: * Adult subjects 18 to 70 years of age * Chronic HCV infection for at least 6 months prior to Baseline (Day 1) * Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis * Monoinfection with HCV genotype 1a or 1b * HCV treatmen...