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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00277238 | CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects | PHASE2 | COMPLETED | 113 | — | — | Feb 1, 2006 | Jul 1, 2007 | Mar 8, 2017 | 14 | United States |
| NCT00142103 | CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Relapsed Hepatitis C Virus (HCV) Subjects | PHASE1 | COMPLETED | 91 | — | — | Sep 1, 2005 | Feb 1, 2007 | May 16, 2011 | 13 | United States |
| Arm | Type | Description |
|---|---|---|
| CPG10101 (0.2) + pegylated inteferon + ribavirin | EXPERIMENTAL | - |
| CPG10101 (0.5) + pegylated inteferon + ribavirin | EXPERIMENTAL | - |
| Pegylated interferon + ribavirin | ACTIVE_COMPARATOR | - |
| CPG10101 + pegylated interferon + ribavirin (rollover) | EXPERIMENTAL | - |
| CPG10101 | EXPERIMENTAL | - |
| CPG10101 + pegylated interferon | EXPERIMENTAL | - |
| CPG10101 + ribavirin | EXPERIMENTAL | - |
| CPG10101 + pegylated interferon + ribavirin | EXPERIMENTAL | - |
| Pegylated inteferon + ribavirin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CPG10101 | DRUG | CPG10101, subcutaneous, 0.2mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks |
| Control | DRUG | Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 12wks |
Inclusion Criteria: HCV positive subjects documented by serum HCV RNA concentration \> 100,000 IU/mL within 21 days of first study treatment Receipt of adequate previous PEG-IFN and RBV therapy for a minimum of 12 weeks (PEG-IFN alpha-2a doses of \> 180 μg/wk or PEG-IFN alpha-2b 1.5 µg/kg/wk and at...