Chronic Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, Liver, Pegylated, Interferon, Alpha, Gamma, Ribavirin, Combination, Nonresponder, Pegasys, PegIntron
Brief summary
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.
Interventions
DRUGConsensus 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
Sponsors
InterMune
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virologic response defined as >2 log (base 10) reduction in HCV RNA | 72 weeks |
Countries
United States
Outcome results
None listed