CIFN and IFN γ-1b With or Without Ribavirin for Treatment of Chronic Hepatitis C (Nonresponders)

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.

Official Title
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Safety and Tolerability of Consensus Interferon-Alpha (CIFN) Plus Interferon Gamma-1b (IFN-γ 1b) With or Without Ribavirin (RBV) in the Treatment of Patients With Chronic Hepatitis C Who Are Non-Responders to PEG-IFN-a (2a or 2b) Plus RBV

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed Male or female 18 years of age or older Chronic hepatitis C infection based on history of positive serum anti-HCV antibody and/or HCV RNA Patients must have documented failure to respond to past treatment with PEG-Intron or Pegasys plus RBV. Liver biopsy within 3 years of screening documenting chronic liver disease consistent with chronic hepatitis C Exclusion Criteria: Patients with any history of decompensated liver disease including but not restricted to portal hypertension as manifested by gastroesophageal varices, variceal bleeding, ascites, or encephalopathy Specific laboratory abnormalities at Screening Patients who were HCV RNA negative during prior pegylated interferon plus ribavirin treatment, but who relapsed during follow-up Recent depression or psychiatric disorders Known HIV infection or positive HIV antibody test at Screening Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at Screening Unstable or uncontrolled thyroid disease Presence or history of non-HCV chronic liver disease History of unstable or deteriorating cardiovascular or cerebrovascular disease within 6 months prior to Screening Current or history of neurologic disorder within a specified time frame A disease known to cause significant alteration in immunologic function including hematological malignancy, sarcoidosis or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, leukemia, lymphoma, autoimmune thyroid disease, scleroderma, psoriasis, inflammatory bowel disease, multiple sclerosis etc.) History of major organ transplantation (i.e., liver, kidney, lung, or heart) with an existing functional graft, including bone marrow transplant or stem cell transplant Concurrent therapy with immunosuppressive drugs or cytotoxic agents such as cyclosporine, azathioprine, chronic systemic corticosteroids, or chemotherapeutic agent(s) (e.g., cyclophosphamide, methotrexate, or cancer chemotherapy) or radiation therapy Pregnant or lactating women Liver biopsy within the past three years documenting cirrhosis

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Drug: Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin|interferon gamma-1b: 0.25 and 0.5 mL, SQ, 3x per week interferon alfacon: 0.3 mL and 0.5 mL, SQ, once a day Ribavirin: 2 capsules in a.m., 3 capsules in p.m.; daily|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic response defined as >2 log (base 10) reduction in HCV RNA |  | 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PegIntron, Chronic Hepatitis C, Liver, Pegylated, Interferon, Alpha, Gamma, Ribavirin, Combination, Nonresponder, Pegasys