- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00047658
A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)
November 2, 2007 updated by: InterMune
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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA, Dept. of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Male or Female 20-79 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 23 weeks
|
23 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Williamson Bradford, MD, InterMune
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Study Completion (Actual)
May 1, 2003
Study Registration Dates
First Submitted
October 9, 2002
First Submitted That Met QC Criteria
October 10, 2002
First Posted (Estimate)
October 11, 2002
Study Record Updates
Last Update Posted (Estimate)
November 6, 2007
Last Update Submitted That Met QC Criteria
November 2, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIPF-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Sheba Medical CenterUnknownIDIOPATHIC PULMONARY FIBROSISIsrael
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Theravance BiopharmaTerminatedIdiopathic Pulmonary Fibrosis (IPF)United Kingdom
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University of California, San FranciscoCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
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BiogenCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
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Liminal BioSciences Ltd.CompletedIdiopathic Pulmonary Fibrosis (IPF)Canada
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