Trials / Completed
CompletedNCT00039871
PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,333 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PegIntron (peginterferon alfa-2b; SCH 54031) | PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks |
| DRUG | REBETOL (ribavirin; SCH 18908) | REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks |
Timeline
- Start date
- 2002-05-01
- Primary completion
- 2007-09-01
- Completion
- 2007-09-01
- First posted
- 2002-06-14
- Last updated
- 2017-04-04
- Results posted
- 2008-12-11
Source: ClinicalTrials.gov record NCT00039871. Inclusion in this directory is not an endorsement.