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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01271790 | A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C | PHASE2 | COMPLETED | 245 | — | — | Oct 1, 2010 | Sep 1, 2013 | Feb 6, 2014 | 144 | United States, Austria +6 |
Sustained virologic response (SVR) defined as undetectable hepatitis C virus (HCV) RNA 24 weeks after treatment cessation
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | GS-9451 and Tegobuvir (GS-9190) 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 | ACTIVE_COMPARATOR | GS-9451 (active) and Tegobuvir (GS-9190) placebo 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 Tegobuvir (GS-9190) and GS-9451 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 |
|---|---|---|
| Tegobuvir (GS-9190) | DRUG | Tegobuvir (GS-9190) capsule, 30 mg BID |
| GS-9451 | DRUG | GS-9451 tablet, 200 mg once daily (QD) |
| Pegasys® | BIOLOGICAL | peginterferon alfa-2a (solution for injection) 180 µg/week |
| Copegus® | DRUG | ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
| Tegobuvir placebo | DRUG | placebo matching Tegobuvir (GS-9190) capsule BID |
| GS-9451 placebo | DRUG | placebo matching GS-9451 tablet QD |
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...