A Study of the Safety and Clinical Effects of 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 2
Status: Completed
Sponsored by: InterMune Official(s) and/or principal investigator(s):
Williamson Bradford, MD, Study Director, Affiliation: InterMune
Summary
Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects
of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects
of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study
will be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment
with corticosteroids.
Clinical Details
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Biology, and Clinical Effects of Interferon Gamma-1b Administered Subcutaneously to Patients With IPF Followed by an Open-Label Extension
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: change in percent predicted FVC, resting arterial blood gas assessment of alveolar-arterial oxygen gradient, percent predicted DLCO, dyspnea scale, baseline dyspnea index/transition dyspnea index
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Male or Female 20-79 years old
Locations and Contacts
UCLA, Dept. of Medicine, Los Angeles, California 90095, United States
Additional Information
Starting date: November 2001
Ending date: May 2003
Last updated: November 2, 2007
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