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A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00047645
Recruitment Status : Completed
First Posted : October 11, 2002
Last Update Posted : November 2, 2007
Sponsor:
Information provided by:
InterMune

Study Description
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Brief Summary:
Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b administered by subcutaneous injection; compared to placebo in patients with IPF who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g 1b group or a placebo group.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Interferon-gamma 1b Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis
Study Start Date : April 2000
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: Interferon-gamma 1b
    200 mcg, SQ, 3x per week

Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival time [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Male or Female, 20-79 years old
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047645


Locations
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United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
InterMune
Investigators
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Study Director: Javier Szwarcberg, MD InterMune
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00047645    
Other Study ID Numbers: GIPF-001
First Posted: October 11, 2002    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: November 2007
Keywords provided by InterMune:
lung
IPF
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
 Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents