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
Information source: InterMune
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Disease; Pulmonary Fibrosis
Intervention: interferon-gamma 1b (Drug); azathioprine (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: InterMune Official(s) and/or principal investigator(s):
Steven Porter, MD, Study Director, Affiliation: InterMune
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: This study was terminated prior to enrollment.
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
Locations and Contacts
Ospedale S. Luigi Gonzaga - Regione, Torino, Orbassano 10043, Italy
Additional Information
Starting date: April 2002
Ending date: June 2002
Last updated: November 2, 2007
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