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)

Phase 2

Completed

• Conditions: Pulmonary Fibrosis; Lung Disease

• Registration Number: NCT00052052
• Lead Sponsor: InterMune

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2003-01-21
• Study First Submitted QC: 2003-01-22
• Study First Posted: 2003-01-23
• Study Completion: 2004-09
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-02
• Last Update Posted: 2007-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States