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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

This study has been terminated.
(Study design changes were needed based on GIPF-001 results)
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00052039
First received: January 21, 2003
Last updated: November 2, 2007
Last verified: November 2007
History of Changes
  Purpose

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 Intervention Phase
Lung Disease
Pulmonary Fibrosis
 Drug: interferon-gamma 1b
Drug: azathioprine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by InterMune:

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

Enrollment: 0
Study Start Date: April 2002
Study Completion Date: June 2002
Intervention Details:
    Drug: interferon-gamma 1b
    This study was terminated prior to enrollment.
    Drug: azathioprine
    This study was terminated prior to enrollment.
  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052039

Locations
Italy
Ospedale S. Luigi Gonzaga - Regione
Torino, Orbassano, Italy, 10043
Sponsors and Collaborators
InterMune
Investigators
Study Director: Steven Porter, MD InterMune
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00052039     History of Changes
Other Study ID Numbers: GIPF-003
Study First Received: January 21, 2003
Last Updated: November 2, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by InterMune:
idiopathic pulmonary fibrosis

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Azathioprine
Interferons
Prednisone
Interferon-gamma
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013