Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (The INSPIRE Trial)
- Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the
efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by
subcutaneous (SC) injection, compared with placebo, in patients with IPF
- Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers
in North America and Europe
- Randomization: 2:1 active-to-placebo ratio
- Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for
patients who meet predefined criteria)
INSPIRE, the largest and most comprehensive clinical trial ever conducted in IPF, has now completed enrolling patients with mild to moderate IPF. Eligible patients will receive either Interferon gamma-1b or placebo for a minimum of 2 years. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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