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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 2,333
- Primary Endpoint
- Sustained Virologic Response (SVR) Rate
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age at entry 18-65
- •Positive for Hepatitis C
- •Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin
- •Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis
Exclusion Criteria
- •Any cause for the liver disease other than chronic hepatitis C
- •History or presence of complications of cirrhosis
- •Alcohol or illicit drug use or methadone treatment within the past 2 years
- •Treatment for chronic hepatitis C within the previous 6 months
- •Diseases or conditions that could interfere with the subject's participation in and completion of the study
Arms & Interventions
Overall study population
Intervention: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological)
Overall study population
Intervention: REBETOL (ribavirin; SCH 18908) (Drug)
Outcomes
Primary Outcomes
Sustained Virologic Response (SVR) Rate
Time Frame: Assessed at end of 24 weeks posttreatment follow-up
Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)
Secondary Outcomes
- Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12(24 weeks posttreatment)
- Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12(24 weeks posttreatment)