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Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis

Primary Purpose

Liver Fibrosis, Cirrhosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
interferon gamma-1b
Sponsored by
InterMune
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Fibrosis focused on measuring hepatitis C, liver fibrosis, liver cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Men or women 18 to 75 years Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA History of prior treatment with interferon-a-based therapies or an assessment by the investigator that the patient would not benefit from interferon-a-based therapy or that treatment with interferon-a is contraindicated Stage 4, 5 or 6 liver fibrosis according to the Ishak scoring system. Cannot have presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding within the last 2 years (diuretic therapy of stable mild-to-moderate peripheral edema is permitted) Must meet minimum blood chemistry requirements Cannot have unstable or uncontrolled thyroid disease Cannot have a variety of other diseases (listed in protocol Other conditions for enrollment exist which would be discussed with a Clinician upon screening for the study.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Ishak fibrosis score

    Secondary Outcome Measures

    Full Information

    First Posted
    August 7, 2002
    Last Updated
    October 29, 2007
    Sponsor
    InterMune
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00043303
    Brief Title
    Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
    Official Title
    A Multicenter Study of the Safety and Anti-Fibrotic Efficacy of Interferon-Gamma 1b (Actimmune) in Patients With Severe Lever Fibrosis or Compensated Cirrhosis Due to Hepatitis C.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    InterMune

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this research study is to test the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of advanced liver fibrosis and cirrhosis in patients with chronic hepatitis C infections. IFN-g 1b is not currently approved for the treatment of liver fibrosis.
    Detailed Description
    This study will evaluate the safety and tolerability of IFN-g 1b in patients with advanced liver fibrosis and cirrhosis due to hepatitis C. This study will also evaluate whether IFN-g 1b is effective in reducing the amount of fibrosis in the liver.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Fibrosis, Cirrhosis
    Keywords
    hepatitis C, liver fibrosis, liver cirrhosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    502 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    interferon gamma-1b
    Intervention Description
    100 or 200 mcg, SQ, 3x per week
    Primary Outcome Measure Information:
    Title
    Ishak fibrosis score
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Men or women 18 to 75 years Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA History of prior treatment with interferon-a-based therapies or an assessment by the investigator that the patient would not benefit from interferon-a-based therapy or that treatment with interferon-a is contraindicated Stage 4, 5 or 6 liver fibrosis according to the Ishak scoring system. Cannot have presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding within the last 2 years (diuretic therapy of stable mild-to-moderate peripheral edema is permitted) Must meet minimum blood chemistry requirements Cannot have unstable or uncontrolled thyroid disease Cannot have a variety of other diseases (listed in protocol Other conditions for enrollment exist which would be discussed with a Clinician upon screening for the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Steven Porter, MD
    Organizational Affiliation
    InterMune
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis

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