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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00987337 | Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects | PHASE2 | COMPLETED | 288 | — | — | Nov 1, 2009 | Jan 1, 2012 | Jan 27, 2014 | 77 | United States, Belgium +7 |
For participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24, SVR was defined as undetectable plasma HCV RNA levels (\<15 IU/mL) at both Week 24 (End of Treatment \[EOT\]) and Week 72, regardless of the HCV RNA levels between Week 24 and 72. For participants who received filibuvir, had detectable HCV RNA at Week 4 or later and discontinued therapy at Week 48 or who received placebo, SVR was defined as undetectable plasma HCV RNA levels (\<15 IU/mL) at both Week 48 (EOT) and Week 72, regardless of the HCV RNA levels between Week 48 and 72.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4) \- or - Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4) |
| Arm B | EXPERIMENTAL | Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4) \- or - Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4) |
| Arm C | PLACEBO_COMPARATOR | Placebo + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks |
| Name | Type | Description |
|---|---|---|
| Filibuvir | DRUG | 300 mg BID |
| Placebo | DRUG | BID |
Inclusion Criteria: * Male or female subjects at least 18 years of age. * HCV seropositive. * HCV RNA \>10,000 IU/mL at screening. * HCV Genotype 1. Subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible. * Treatment naïve (no prior treatment with IFN alfa +/ RBV regimen...