Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin

Study Overview
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Brief Summary
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This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and Ribavirin therapy. The study will be conducted at approximately 50 sites across the United States.

Official Title
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Phase 4 Study Using Infergen and Ribavirin in Patients With Chronic Hepatitis C Virus Who Achieved Partial Response to Peginterferon-alfa and Ribavirin Therapy

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Infergen and ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, at least 18 years of age and no older than 65 years with compensated chronic HCV infection based on a history of positive serum anti-HCV antibody and/or HCV RNA Diagnosed with HCV Genotype 1, 4, 5 or 6 as determined during the screening visit The starting doses in the initial treatment must have been 1.5 μg/kg/week PEG-Intron or 180 μg/week Pegasys, and 1000/1200 mg/day ribavirin based on body weight. Patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account. Liver biopsy indicating F0-F4 must be performed within 3 years prior to screening. Documentation of the results of the biopsy must be available. If documentation is not available, a liver biopsy must be performed during the screening period. (A maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of F4) Documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (PEGASYS) and Ribavirin or peginterferon alfa-2b (Peg-INTRON) and Ribavirin Exclusion Criteria: Detectable HCV RNA after 12 weeks if initial peginterferon alfa/ribavirin therapy and <2 log decrease in HCV RNA at Week 12 from baseline. HCV Genotype 2 or 3 Severe neuropsychiatric disorder. History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease. Known HIV infection or positive HIV at screening. Pregnant or breast-feeding patients. Underlying autoimmune disease

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Infergen 15 ug QD plus RBV for 36 weeks | Drug: Infergen and ribavirin<br>* Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks<br>|
| Experimental: 2<br>Infergen 15 ug QD plus RBV for 48 weeks | Drug: Infergen and ribavirin<br>* Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks<br>|
| Active Comparator: 3<br> | Drug: Infergen and ribavirin<br>* Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the proportion of patients with a sustained viral response (SVR) defined as undetectable serum HCV RNA at the end of the 24 week post-treatment follow-up period. |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks |  | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis C, Liver, Pegylated, Interferon, Ribavirin, Combination, Nonresponder, Relapser, HCV, Infergen, SVR