Phase 3
Completed N=2,312
PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
Source: ClinicalTrials.gov NCT00039871 ↗Enrolled (actual)
2,312
Serious AEs
8.6%
Results posted
Dec 2008
Primary outcomePrimary: Sustained Virologic Response (SVR) Rate — 497 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virologic Response (SVR) Rate |
497 | — |
| SECONDARY Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 |
463 | — |
| SECONDARY Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 |
23 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00039871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.