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

NCT00084279 | Completed Phase 2

• 1 other identifier: AGHC-002
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C; Liver; Pegylated; Interferon; Alpha; Gamma; Ribavirin; Combination; Nonresponder; Pegasys; PegIntron

Outcome Measures

Primary Outcomes (1)

• Virologic response defined as >2 log (base 10) reduction in HCV RNA

  72 weeks

Interventions

Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin DRUG

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InterMune: lead

Study Sites (1)

InterMune, Inc.

Brisbane, California, 94005, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

interferon gamma-1b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Matthew McClure, MD

  InterMune

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2004
• First Posted: June 11, 2004
• Study Start: April 1, 2004
• Study Completion: April 1, 2006
• Last Updated: July 3, 2009

Record last verified: 2009-07

Locations

US (1)