An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
Phase 3
Terminated
- Conditions
- Idiopathic Pulmonary FibrosisPulmonary FibrosisLung Disease
- Registration Number
- NCT00076635
- Lead Sponsor
- InterMune
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 91
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method All adverse events up to the end of study 3.5 years Survival status at end of study 3.5 years Serum antibodies to Interferon gamma-1b after the last injection. 3.5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Intermune Inc
🇺🇸Brisbane, California, United States