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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00049842 |
Purpose
The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of fibrosis progression in adult subjects with moderate to severe liver fibrosis secondary to chronic hepatitis, who failed PEG-Intron plus Rebetol treatment in protocol P02370.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C Liver Fibrosis |
Biological: peginterferon alfa-2b (SCH 54031) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | PEG-Intron(TM) Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects With Chronic Hepatitis C With Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), Who Failed Therapy With PEG-Intron Plus REBETOL(R) (in Protocol No. P02370) |
| Estimated Enrollment: | 700 |
| Study Start Date: | October 2002 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
PegIntron (peginterferon alfa-2b) 0.5 µg/kg QW: Experimental
PegIntron 0.5 µg/kg QW SC as maintenance therapy for 36 months with 4-week follow-up
|
Biological: peginterferon alfa-2b (SCH 54031)
0.5 µg/kg QW SC for 36 months
|
| Untreated Control: No Intervention |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P02570 |
| Study First Received: | November 14, 2002 |
| Last Updated: | October 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00049842 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Liver Diseases RNA Virus Infections Hepatitis, Chronic Flaviviridae Infections Fibrosis Hepatitis, Viral, Human Liver Cirrhosis Antiviral Agents |
Pharmacologic Actions Hepatitis Virus Diseases Pathologic Processes Digestive System Diseases Therapeutic Uses Peginterferon alfa-2b Hepatitis C Hepatitis C, Chronic |