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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00049842 | Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED) | PHASE3 | COMPLETED | 540 | — | — | Oct 1, 2002 | Oct 1, 2009 | Apr 4, 2017 | - | — |
| NCT00048724 | Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569) | PHASE3 | COMPLETED | 631 | — | — | Jun 1, 2002 | Apr 1, 2008 | Apr 4, 2017 | - | — |
Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
Clinical events are liver decompensation \[variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites\], hepatic carcinoma, death, and/or liver transplantation
| Arm | Type | Description |
|---|---|---|
| PEG-Intron (peginterferon alfa-2b) 0.5 µg/kg Weekly (QW) | EXPERIMENTAL | PEG-Intron 0.5 µg/kg Weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up |
| Untreated Control | NO_INTERVENTION | - |
| PegIntron | EXPERIMENTAL | PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up |
| Name | Type | Description |
|---|---|---|
| peginterferon alfa-2b (SCH 54031) | BIOLOGICAL | 0.5 µg/kg Weekly QW SC for 36 months |
Inclusion Criteria: * Age at entry in study P02370 (NCT00039871) 18-65 years; * Nonresponder to PEG-Intron plus Rebetol in study P02370 Exclusion Criteria: * Participants who did not participate in the P02370 study. * Any medical condition, including but not limited to decompensated liver disease...