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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00081770 | Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471) | PHASE3 | COMPLETED | 4,469 | — | — | Mar 1, 2004 | Nov 1, 2007 | Apr 4, 2017 | - | — |
| NCT00787371 | Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED) | PHASE2 | COMPLETED | 69 | — | — | Jun 1, 2005 | Jul 1, 2006 | Mar 13, 2017 | - | — |
SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.
| Arm | Type | Description |
|---|---|---|
| PegIntron 1.5 ug/kg/wk plus REBETOL | EXPERIMENTAL | PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up |
| PegIntron 1.0 ug/kg/wk plus REBETOL | EXPERIMENTAL | PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up |
| PEGASYS 180 ug/wk Plus COPEGUS | ACTIVE_COMPARATOR | PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up |
| 0.25 Dose Group | EXPERIMENTAL | PegIntron 0.25 mcg/kg SC QW for 12 weeks |
| 0.5 Dose Group | EXPERIMENTAL | PegIntron 0.5 mcg/kg SC QW for 12 weeks |
| 1.0 Dose Group | EXPERIMENTAL | PegIntron 1.0 mcg/kg SC QW for 12 weeks |
| No-treatment Control | NO_INTERVENTION | No treatment (no placebo) |
| Name | Type | Description |
|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031) | BIOLOGICAL | 1.5 ug/kg/week subcutaneously (SC) for 48 weeks |
| REBETOL (ribavirin; SCH 18908) | DRUG | weight based dose 800-1400 mg/day orally (PO) for 48 weeks |
| PEGASYS (peginterferon alfa-2a) | BIOLOGICAL | 180 ug/week SC administered for 48 weeks |
| COPEGUS (ribavirin) | DRUG | 1000-1200 mg/day PO for 48 weeks |
| PegIntron (peginterferon alfa-2b) | BIOLOGICAL | PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks |
INCLUSION CRITERIA: * Previously untreated adults with chronic hepatitis C (hepatitis C virus ribonucleic acid \[HCV RNA\] quantitative polymerase chain reaction \[qPCR\] plasma positive) * Individuals with HCV genotype 1 (mixed 1a/1b is acceptable) * Compensated liver disease * Pretreatment liver ...