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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:

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2004
Actual Study Completion Date : April 2006

Intervention Details:
  • 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

Primary Outcome Measures :
  1. Virologic response defined as >2 log (base 10) reduction in HCV RNA [ Time Frame: 72 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084279

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United States, California
InterMune, Inc.
Brisbane, California, United States, 94005
Sponsors and Collaborators
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Study Director: Matthew McClure, MD InterMune
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ClinicalTrials.gov Identifier: NCT00084279    
Other Study ID Numbers: AGHC-002
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: July 3, 2009
Last Verified: July 2009
Keywords provided by InterMune:
Chronic Hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Interferon alfacon-1
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs