Back to resultsAn Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Primary Purpose
Lung Disease, Pulmonary Fibrosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
interferon-gamma 1b
Sponsored by
About this trial
This is an interventional treatment trial for Lung Disease focused on measuring idiopathic pulmonary fibrosis, IPF
Eligibility Criteria
Male or Female Idiopathic Pulmonary Fibrosis 20-79 years Must have participated in the InterMune protocol GIPF-001 study.
Sites / Locations
- University of Washington Medical Center
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00052052
Brief Title
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)
Official Title
An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
InterMune
4. Oversight
5. Study Description
Brief 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.
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, IPF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
interferon-gamma 1b
Intervention Description
200 mcg, SQ, 3x per week
Primary Outcome Measure Information:
Title
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
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Male or Female
Idiopathic Pulmonary Fibrosis
20-79 years
Must have participated in the InterMune protocol GIPF-001 study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Szwarcberg, MD
Organizational Affiliation
InterMune
Official's Role
Study Director
Facility Information:
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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)
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