At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years
- ✓Confirmed hepatitis C infection
- ✓Prior nonresponse to alpha interferon plus ribavirin combination for minimum 3 months
- ✓Liver biopsy showing moderate to severe fibrosis or cirrhosis
- ✕Liver disease from causes other than chronic hepatitis C
- ✕History or presence of cirrhosis complications
- ✕Alcohol or illicit drug use or methadone treatment within past 2 years
- ✕Prior hepatitis C treatment within 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PEG-Intron Plus REBETOL for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (Any Alpha Interferon Treatment in Combination With Ribavirin)
In Brief
A Phase 3 clinical trial evaluating PegIntron (peginterferon alfa-2b; SCH 54031) and REBETOL (ribavirin; SCH 18908) for Hepatitis and 3 related conditions. Completed, enrolled 2,333 participants.
Detailed Summary
The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).
Study Details
Timeline
Interventions
PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks
REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks