PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Hepatitis, Hepatitis C, Chronic, Fibrosis, Liver Cirrhosis

Intervention / Treatment
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* Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
* Drug: REBETOL (ribavirin; SCH 18908)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overall study population<br> | Biological: PegIntron (peginterferon alfa-2b; SCH 54031)<br>* PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks<br>* Other names: SCH 54031;Drug: REBETOL (ribavirin; SCH 18908)<br>* REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response (SVR) Rate | Number of participants with undetectable hepatitis C virus RNA (HCV-RNA) | Assessed at end of 24 weeks posttreatment follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 | Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up | 24 weeks posttreatment | 
| Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 | Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up | 24 weeks posttreatment |