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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)

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ClinicalTrials.gov Identifier: NCT00052052
Recruitment Status : Completed
First Posted : January 23, 2003
Last Update Posted : November 6, 2007
Sponsor:
Information provided by:
InterMune

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Disease Pulmonary Fibrosis Drug: interferon-gamma 1b Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis.
Study Start Date : September 2002
Actual Study Completion Date : September 2004



Intervention Details:
    Drug: interferon-gamma 1b
    200 mcg, SQ, 3x per week


Primary Outcome Measures :
  1. FVC, dyspnea, DLCO, A-a gradient at rest,SGRQ,survival time, use of supplemental oxygen, QOL SF-36, TLC, time to lung transplantation or death due to IPF [ Time Frame: 48 weeks ]


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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

Idiopathic Pulmonary Fibrosis

20-79 years

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


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): NCT00052052


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

ClinicalTrials.gov Identifier: NCT00052052     History of Changes
Other Study ID Numbers: GIPF-004
First Posted: January 23, 2003    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: November 2007

Keywords provided by InterMune:
idiopathic pulmonary fibrosis
IPF

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