An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Sponsor

InterMune (Industry)

Overall Status

Completed

CT.gov ID

NCT00052052

Collaborator

(none)

210

Enrollment

Location

Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250 patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up to 48 weeks.

Condition or Disease	Intervention/Treatment	Phase
Lung Disease Pulmonary Fibrosis	Drug: interferon-gamma 1b	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2002

Actual Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

FVC, dyspnea, DLCO, A-a gradient at rest,SGRQ,survival time, use of supplemental oxygen, QOL SF-36, TLC, time to lung transplantation or death due to IPF [48 weeks]