A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Information source: InterMune
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Pulmonary Fibrosis
Intervention: Interferon-gamma 1b (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: InterMune Official(s) and/or principal investigator(s):
Javier Szwarcberg, MD, Study Director, Affiliation: InterMune
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Progression-free survival time
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Male or Female, 20-79 years old
Locations and Contacts
University of Washington Medical Center, Seattle, Washington 98195, United States
Additional Information
Starting date: April 2000
Ending date: December 2002
Last updated: November 1, 2007
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