Back to resultsA 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
Primary Purpose
Lung Disease, Pulmonary Fibrosis
Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
interferon-gamma 1b
azathioprine
Sponsored by
About this trial
This is an interventional treatment trial for Lung Disease focused on measuring idiopathic pulmonary fibrosis
Eligibility Criteria
Sites / Locations
- Ospedale S. Luigi Gonzaga - Regione
Outcomes
Primary Outcome Measures
This study was terminated prior to enrollment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00052039
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Why Stopped
Study design changes were needed based on GIPF-001 results
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
InterMune
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease, Pulmonary Fibrosis
Keywords
idiopathic pulmonary fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
interferon-gamma 1b
Intervention Description
This study was terminated prior to enrollment.
Intervention Type
Drug
Intervention Name(s)
azathioprine
Intervention Description
This study was terminated prior to enrollment.
Primary Outcome Measure Information:
Title
This study was terminated prior to enrollment.
Time Frame
This study was terminated prior to enrollment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Porter, MD
Organizational Affiliation
InterMune
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale S. Luigi Gonzaga - Regione
City
Torino
State/Province
Orbassano
ZIP/Postal Code
10043
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
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
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