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.
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.
- 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
- pregnancy or lactation
- lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment
- if Principal Investigator deems patient is unsuitable for study