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

InterMune

Status and phase

Terminated

Phase 3

Conditions

Pulmonary Fibrosis

Lung Disease

Idiopathic Pulmonary Fibrosis

Treatments

Drug: Interferon gamma-1b

Study type

Interventional

Funder types

Industry

Identifiers

NCT00076635

GIPF-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

91 patients

Sex

All

Volunteers

No Healthy Volunteers

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