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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047645
First Posted: October 11, 2002
Last Update Posted: November 2, 2007
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.
Information provided by:
InterMune
  Purpose
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 Intervention Phase
Idiopathic Pulmonary Fibrosis Drug: Interferon-gamma 1b Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by InterMune:

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

Enrollment: 330
Study Start Date: April 2000
Study Completion Date: December 2002
Intervention Details:
    Drug: Interferon-gamma 1b
    200 mcg, SQ, 3x per week
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Male or Female, 20-79 years old
  Contacts and Locations
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
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
InterMune
Investigators
Study Director: Javier Szwarcberg, MD InterMune
  More Information

ClinicalTrials.gov Identifier: NCT00047645     History of Changes
Other Study ID Numbers: GIPF-001
First Submitted: October 9, 2002
First Posted: October 11, 2002
Last Update Posted: November 2, 2007
Last Verified: November 2007

Keywords provided by InterMune:
lung
IPF

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents