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

 1. Signed, written, informed consent from the patient or legal representative before any
 study-specific procedures are performed

 2. Male or female 18 years of age or older

 3. Chronic hepatitis C infection based on history of positive serum anti-HCV antibody
 and/or HCV RNA

 4. Patients must have documented failure to respond to past treatment with PEG-Intron or
 Pegasys plus RBV.

 5. Liver biopsy within 3 years of screening documenting chronic liver disease consistent
 with chronic hepatitis C

 Exclusion Criteria:

 1. 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

 2. Specific laboratory abnormalities at Screening

 3. Patients who were HCV RNA negative during prior pegylated interferon plus ribavirin
 treatment, but who relapsed during follow-up

 4. Recent depression or psychiatric disorders

 5. Known HIV infection or positive HIV antibody test at Screening

 6. Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at
 Screening

 7. Unstable or uncontrolled thyroid disease

 8. Presence or history of non-HCV chronic liver disease

 9. History of unstable or deteriorating cardiovascular or cerebrovascular disease within
 6 months prior to Screening

 10. Current or history of neurologic disorder within a specified time frame

 11. 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.)

 12. 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

 13. 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

 14. Pregnant or lactating women

 15. Liver biopsy within the past three years documenting cirrhosis