Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075998
Status:
TERMINATED
Last Update Posted:
2009-07-02
First Post:
2004-01-12
Brief Title:
The INSPIRE Trial A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis IPF
Sponsor:
InterMune
Organization:
InterMune
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
test drug showed lack of benefit at interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 21 active-to-placebo ratio
Duration at least 2 years active drug or placebo rescue therapy will be permitted for patients who meet predefined criteria
Enrollment Approximately 800 patients will be enrolled from approximately 80 centers in North America and Europe
Randomization 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None