Back to resultsAn Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
Primary Purpose
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Disease
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Interferon gamma-1b
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic, Pulmonary, Fibrosis, IPF, Lung, Actimmune, Interferon, Gamma, InterMune
Eligibility Criteria
Inclusion criteria: Enrollment in Protocol GIPF 002 Part B or GIPF-004 Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004 Able to understand and sign a written informed consent form and comply with the requirements of the study Exclusion criteria: pregnancy or lactation lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens if Principal Investigator deems patient is unsuitable for study
Sites / Locations
- Intermune Inc
Outcomes
Primary Outcome Measures
All adverse events up to the end of study
Survival status at end of study
Serum antibodies to Interferon gamma-1b after the last injection.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00076635
Brief Title
An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
Official Title
An Open-Label Study of the Safety 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
Terminated
Why Stopped
program discontinued based on GIPF-007 results
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
InterMune
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.
Detailed Description
Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Disease
Keywords
Idiopathic, Pulmonary, Fibrosis, IPF, Lung, Actimmune, Interferon, Gamma, InterMune
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (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
All adverse events up to the end of study
Time Frame
3.5 years
Title
Survival status at end of study
Time Frame
3.5 years
Title
Serum antibodies to Interferon gamma-1b after the last injection.
Time Frame
3.5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Enrollment in Protocol GIPF 002 Part B or GIPF-004
Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004
Able to understand and sign a written informed consent form and comply with the requirements of the study
Exclusion criteria:
pregnancy or lactation
lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens
if Principal Investigator deems patient is unsuitable for study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
InterMune, Inc. 888-486-6411
Organizational Affiliation
Medical Information
Facility Information:
Facility Name
Intermune Inc
City
Brisbane
State/Province
California
ZIP/Postal Code
94005
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
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