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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin
Sponsored by
InterMune
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C, Liver, Pegylated, Interferon, Alpha, Gamma, Ribavirin, Combination, Nonresponder, Pegasys, PegIntron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • InterMune, Inc.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 9, 2004
Last Updated
July 1, 2009
Sponsor
InterMune
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1. Study Identification

Unique Protocol Identification Number
NCT00084279
Brief Title
CIFN and IFN γ-1b With or Without Ribavirin for Treatment of Chronic Hepatitis C (Nonresponders)
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
InterMune

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic Hepatitis C, Liver, Pegylated, Interferon, Alpha, Gamma, Ribavirin, Combination, Nonresponder, Pegasys, PegIntron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin
Intervention Description
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 Measure Information:
Title
Virologic response defined as >2 log (base 10) reduction in HCV RNA
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew McClure, MD
Organizational Affiliation
InterMune
Official's Role
Study Director
Facility Information:
Facility Name
InterMune, Inc.
City
Brisbane
State/Province
California
ZIP/Postal Code
94005
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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