The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary FibrosisLung DiseasePulmonary Fibrosis
- Registration Number
- NCT00075998
- Lead Sponsor
- InterMune
- Brief Summary
* 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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 826
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Survival time from randomization to treatment completion visit, or, end of treatment period, or, last known vital status. 3.5 years
- Secondary Outcome Measures
Name Time Method Lung transplant-free survival time (ongoing assessment up to end of study). 3.5 years Total number of days without hospitalization resulting from respiratory admission diagnosis (ongoing assessment up to end of study). 3.5 years Changes from baseline measurement to week 96 measurement in the following (measured every 24 weeks): 6-minute walk test, shortness of breath 96 weeks
Trial Locations
- Locations (1)
InterMune, Inc.
🇺🇸Brisbane, California, United States