An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-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: Lung Disease; Pulmonary Fibrosis
Intervention: interferon-gamma 1b (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: InterMune Official(s) and/or principal investigator(s):
Javier Szwarcberg, MD, Study Director, Affiliation: InterMune
Summary
Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250
patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety
and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up
to 48 weeks.
Clinical Details
Official title: An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis.
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: FVC, dyspnea, DLCO, A-a gradient at rest,SGRQ,survival time, use of supplemental oxygen, QOL SF-36, TLC, time to lung transplantation or death due to IPF
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Male or Female
Idiopathic Pulmonary Fibrosis
20-79 years
Must have participated in the InterMune protocol GIPF-001 study.
Locations and Contacts
University of Washington Medical Center, Seattle, Washington 98195, United States
Additional Information
Starting date: September 2002
Ending date: September 2004
Last updated: November 2, 2007
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