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Descriptive Information Fields | |||||
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Brief Title † | A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF) | ||||
Official Title † | 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 | ||||
Brief Summary | 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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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||
Primary Outcome Measure † | Progression-free survival time [ Time Frame: 2 years ] | ||||
Secondary Outcome Measure † | |||||
Condition † | Idiopathic Pulmonary Fibrosis | ||||
Intervention † | Drug: Interferon-gamma 1b | ||||
MEDLINE PMIDs | |||||
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Recruitment Information Fields | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 330 | ||||
Start Date † | April 2000 | ||||
Completion Date | December 2002 | ||||
Eligibility Criteria † | Male or Female, 20-79 years old |
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Gender | Both | ||||
Ages | 20 Years to 79 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00047645 | ||||
Organization ID | GIPF-001 | ||||
Secondary IDs †† | |||||
Study Sponsor † | InterMune | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | InterMune | ||||
Verification Date | November 2007 | ||||
First Received Date † | October 9, 2002 | ||||
Last Updated Date | November 1, 2007 |