Trials / Completed
CompletedNCT00049842
Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 540 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | peginterferon alfa-2b (SCH 54031) | 0.5 µg/kg Weekly QW SC for 36 months |
Timeline
- Start date
- 2002-10-01
- Primary completion
- 2009-10-01
- Completion
- 2009-10-01
- First posted
- 2002-11-15
- Last updated
- 2017-04-04
- Results posted
- 2011-01-20
Source: ClinicalTrials.gov record NCT00049842. Inclusion in this directory is not an endorsement.