An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2004-09-30

Brief Summary

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Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250 patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up to 48 weeks.

Detailed Description

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Conditions

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Lung Disease Pulmonary Fibrosis

Keywords

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idiopathic pulmonary fibrosis IPF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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interferon-gamma 1b

200 mcg, SQ, 3x per week

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Male or Female

Idiopathic Pulmonary Fibrosis

20-79 years

Must have participated in the InterMune protocol GIPF-001 study.

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Javier Szwarcberg, MD

Role: STUDY_DIRECTOR

InterMune

Locations

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University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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GIPF-004

Identifier Type: -

Identifier Source: org_study_id