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

Condition(s) targeted: Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Disease

Intervention: Interferon gamma-1b (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: InterMune

Official(s) and/or principal investigator(s):
InterMune, Inc. 888-486-6411, Affiliation: Medical Information

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.

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

All adverse events up to the end of study

Survival status at end of study

Serum antibodies to Interferon gamma-1b after the last injection.

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Intermune Inc, Brisbane, California 94005, United States

Starting date: November 2003
Last updated: November 2, 2007