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

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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00043303
Enrollment
502
Registered
2002-08-09
Start date
2001-09-30
Completion date
2003-11-30
Last updated
2007-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver Fibrosis

Keywords

hepatitis C, liver fibrosis, liver cirrhosis

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.

Interventions

DRUGinterferon gamma-1b

100 or 200 mcg, SQ, 3x per week

Sponsors

InterMune
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Ishak fibrosis score52 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026