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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00084279
• Other study ID #: AGHC-002
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2004
• Last updated: July 1, 2009
• Start date: April 2004
• Est. completion date: April 2006

Study information

• Verified date: July 2009
• Source: InterMune
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	InterMune, Inc.	Brisbane	California

Sponsors (1)

Lead Sponsor	Collaborator
InterMune

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic response defined as >2 log (base 10) reduction in HCV RNA		72 weeks