Status:
COMPLETED
CIFN and IFN γ-1b With or Without Ribavirin for Treatment of Chronic Hepatitis C (Nonresponders)
Lead Sponsor:
InterMune
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-responde...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00084279
Start Date
April 1 2004
End Date
April 1 2006
Last Update
July 3 2009
Active Locations (1)
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1
InterMune, Inc.
Brisbane, California, United States, 94005