Status:
TERMINATED
An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
Lead Sponsor:
InterMune
Conditions:
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Eligibility:
All Genders
Phase:
PHASE3
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 In...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00076635
Start Date
November 1 2003
End Date
April 1 2007
Last Update
November 6 2007
Active Locations (1)
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1
Intermune Inc
Brisbane, California, United States, 94005