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

January 21, 2003
November 2, 2007
April 2002
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This study was terminated prior to enrollment. [ Time Frame: This study was terminated prior to enrollment. ]
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Complete list of historical versions of study NCT00052039 on ClinicalTrials.gov Archive Site
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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
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 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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Lung Disease
  • Pulmonary Fibrosis
  • Drug: interferon-gamma 1b
    This study was terminated prior to enrollment.
  • Drug: azathioprine
    This study was terminated prior to enrollment.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
June 2002
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Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00052039
GIPF-003
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InterMune
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Study Director: Steven Porter, MD InterMune
InterMune
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP