| November 6, 2002 |
| October 13, 2009 |
| June 2002 |
| April 2008 (final data collection date for primary outcome measure) |
| Time to Observation of the First Clinical Event Experienced by a Subject [ Time Frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ] [ Designated as safety issue: Yes ] |
| Time to development of the first clinical event experienced by a subject. Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], HCC, death, and/or liver transplantation [ Time Frame: 60-month treatment or observation (untreated control), 4-week follow-up. Clinical events documented by the end of the study period (defined as the time when the first subject has been in the study for 5 years) will be included in the efficacy analysis. ] [ Designated as safety issue: Yes ] |
| Complete list of historical versions of study NCT00048724 on ClinicalTrials.gov Archive Site |
| Time to Observation of the Disease Progression Experienced by a Subject [ Time Frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ] [ Designated as safety issue: Yes ] |
| Time to disease progression; proportion of subjects with disease progression; time to each clinical event; additional events (development of Child-Pugh Class B, emergence of varices, enlargement of pre-existing varices); liver-related death. [ Time Frame: 60-month treatment or observation (untreated control), 4-week follow-up. All subjects end participation when the first subject has been in the study for 5 years. ] [ Designated as safety issue: Yes ] |
| |
| Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569AM2)(COMPLETED) |
| PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin |
The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
- Chronic Hepatitis C
- Cirrhosis
|
| Biological: peginterferon alfa-2b (SCH 54031) |
| 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 |
| |
| |
| Completed |
| 631 |
| April 2008 |
| April 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Age at entry 18-65 years;
- Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;
- Liver biopsy demonstrating cirrhosis
Exclusion Criteria:
- Any other cause for liver disease other than chronic hepatitis C;
- History or presence of complications of cirrhosis;
- Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
- Diseases or conditions that could interfere with participation in the study
|
| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00048724 |
| Head, Clinical Trials Registry & Results Disclosure, Schering-Plough |
| P02569 |
| Schering-Plough |
|
|
| Schering-Plough |
| October 2009 |
