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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01371604 | Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005) | PHASE2 | COMPLETED | 68 | — | — | Jul 1, 2011 | Oct 1, 2014 | Feb 6, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| IDX184 50 mg + Peg-IFN/RBV | EXPERIMENTAL | IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. |
| IDX184 100 mg + Peg-IFN/RBV | EXPERIMENTAL | IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. |
| Name | Type | Description |
|---|---|---|
| IDX184 | DRUG | IDX184 50 mg tablet administered orally |
| Peginterferon alfa-2a (Peg-IFN) | BIOLOGICAL | Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly |
| Ribavirin (RBV) | DRUG | Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight. |
| Placebo | DRUG | Matching placebo to IDX184 50 mg tablet administered orally |
Inclusion Criteria: * Males and females with documented genotype 1, chronic hepatitis C infection. * Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs. * Has not received prior antiviral treatment for HCV. * Written informed consent by...