A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT00047645 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330
Last updated 2007-11-02
Summary
Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b administered by subcutaneous injection; compared to placebo in patients with IPF who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g 1b group or a placebo group.
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
- QUADRUPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-04-30
- Completion
- 2002-12-31
Countries
- United States
Study Locations
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