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)
NCT00052052 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2007-11-06
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.
Conditions
Interventions
- DRUG
-
interferon-gamma 1b
200 mcg, SQ, 3x per week
Sponsors & Collaborators
-
InterMune
lead INDUSTRY
Principal Investigators
-
Javier Szwarcberg, MD · InterMune
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-09-30
- Completion
- 2004-09-30
Countries
- United States
Study Locations
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