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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2003-11-30

Brief Summary

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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

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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.

Conditions

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Liver Fibrosis Cirrhosis

Keywords

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hepatitis C liver fibrosis liver cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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interferon gamma-1b

100 or 200 mcg, SQ, 3x per week

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Steven Porter, MD

Role: STUDY_DIRECTOR

InterMune

Other Identifiers

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GILF-001

Identifier Type: -

Identifier Source: org_study_id