NCT00076635

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

An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: InterMune · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis
• Lung Disease

Interventions

Type	Name	Description
DRUG	Interferon gamma-1b	200 mcg, SQ, 3x per week

Timeline

• Start date: 2003-11-01
• Completion: 2007-04-01
• First posted: 2004-01-30
• Last updated: 2007-11-06

Locations

1 site across 1 country: United States