An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InterMune
• Treatments: Interferon-gamma; Interferons

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