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

This study has been completed.
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00047645
First received: October 9, 2002
Last updated: November 1, 2007
Last verified: November 2007

October 9, 2002
November 1, 2007
April 2000
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Progression-free survival time [ Time Frame: 2 years ]
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Complete list of historical versions of study NCT00047645 on ClinicalTrials.gov Archive Site
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A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
Drug: Interferon-gamma 1b
200 mcg, SQ, 3x per week
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
December 2002
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Male or Female, 20-79 years old

Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00047645
GIPF-001
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InterMune
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Study Director: Javier Szwarcberg, MD InterMune
InterMune
November 2007

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