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

• ClinicalTrials.gov Identifier: NCT00084279
• Recruitment Status: Completed
• First Posted: June 11, 2004
• Last Update Posted: July 3, 2009
• Sponsor: InterMune
• Information provided by: InterMune

Tracking Information

• First Submitted Date: June 9, 2004
• First Posted Date: June 11, 2004
• Last Update Posted Date: July 3, 2009
• Study Start Date: April 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: October 29, 2007): Virologic response defined as >2 log (base 10) reduction in HCV RNA [ Time Frame: 72 weeks ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CIFN and IFN γ-1b With or Without Ribavirin for Treatment of Chronic Hepatitis C (Nonresponders)
• Official Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Hepatitis C

Intervention

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

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 29, 2007): 81
• Original Enrollment (submitted: June 23, 2005): 80
• Actual Study Completion Date: April 2006
• Primary Completion Date: Not Provided

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00084279
• Other Study ID Numbers: AGHC-002
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: InterMune
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Matthew McClure, MD; InterMune

• PRS Account: InterMune
• Verification Date: July 2009