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

NCT ID: NCT00084279

Last Updated: 2009-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InterMune

INDUSTRY

Sponsor Role: lead

Principal Investigators

Matthew McClure, MD

Role: STUDY_DIRECTOR

InterMune

Locations

InterMune, Inc.

Brisbane, California, United States

Countries

United States

Other Identifiers

AGHC-002

Identifier Type: -

Identifier Source: org_study_id