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A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone

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ClinicalTrials.gov Identifier: NCT00052039
Recruitment Status : Terminated (Study design changes were needed based on GIPF-001 results)
First Posted : January 22, 2003
Last Update Posted : November 6, 2007
Sponsor:
Information provided by:
InterMune

Study Description
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Brief Summary:
Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210 patients.

Condition or disease Intervention/treatment Phase
Lung Disease Pulmonary Fibrosis Drug: interferon-gamma 1b Drug: azathioprine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Three-Arm, Phase IIIb Study Comparing the Safety and Efficacy of Interferon Gamma-1b Alone, IFN-Gamma 1b With Azathioprine, and Azathioprine Alone in Patients With Idiopathic Pulmonary Fibrosis Receiving Prednisone
Study Start Date : April 2002
Actual Study Completion Date : June 2002

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Arms and Interventions
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Intervention Details:
  • Drug: interferon-gamma 1b
    This study was terminated prior to enrollment.
  • Drug: azathioprine
    This study was terminated prior to enrollment.

Outcome Measures
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Primary Outcome Measures :
  1. This study was terminated prior to enrollment. [ Time Frame: This study was terminated prior to enrollment. ]

Eligibility Criteria
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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
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): NCT00052039


Locations
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Italy
Ospedale S. Luigi Gonzaga - Regione
Torino, Orbassano, Italy, 10043
Sponsors and Collaborators
InterMune
Investigators
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Study Director: Steven Porter, MD InterMune
More Information
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ClinicalTrials.gov Identifier: NCT00052039    
Other Study ID Numbers: GIPF-003
First Posted: January 22, 2003    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: November 2007
Keywords provided by InterMune:
idiopathic pulmonary fibrosis
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Interferons
Interferon-gamma
Azathioprine
Antineoplastic Agents
 Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents