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

This study has been completed.
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00084279
First received: June 9, 2004
Last updated: July 1, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Chronic Hepatitis C
Drug: Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by InterMune:

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

Enrollment: 81
Study Start Date: April 2004
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084279

Locations
United States, California
InterMune, Inc.
Brisbane, California, United States, 94005
Sponsors and Collaborators
InterMune
Investigators
Study Director: Matthew McClure, MD InterMune
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00084279     History of Changes
Other Study ID Numbers: AGHC-002
Study First Received: June 9, 2004
Last Updated: July 1, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by InterMune:
Chronic Hepatitis C
Liver
Pegylated
Interferon
Alpha
Gamma
Ribavirin
Combination
Nonresponder
Pegasys
PegIntron

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferon-gamma
Interferons
Ribavirin
Interferon alfacon-1
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 14, 2014