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

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

Tracking Information
First Submitted Date  ICMJE June 9, 2004
First Posted Date  ICMJE June 11, 2004
Last Update Posted Date July 3, 2009
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
Virologic response defined as >2 log (base 10) reduction in HCV RNA [ Time Frame: 72 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE CIFN and IFN γ-1b With or Without Ribavirin for Treatment of Chronic Hepatitis C (Nonresponders)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE 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  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2007)
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
Actual Study Completion Date  ICMJE April 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00084279
Other Study ID Numbers  ICMJE AGHC-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE InterMune
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Matthew McClure, MD InterMune
PRS Account InterMune
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP