Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131274
Status:
COMPLETED
Last Update Posted:
2005-10-05
First Post:
2005-08-17
Brief Title:
Gleevec Idiopathic Pulmonary Fibrosis IPF Study
Sponsor:
Daniels Craig E MD
Organization:
Daniels Craig E MD
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized Study of the Efficacy Gleevec Imatinib Mesylate in Patients With Idiopathic Pulmonary Fibrosis
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the safety and efficacy of Gleevec imatinib mesylate in the treatment of idiopathic pulmonary fibrosis IPF
Detailed Description:
This is a multicenter double-blind parallel placebo-controlled randomized phase 2 study to evaluate the safety and efficacy of Gleevec imatinib mesylate in the treatment of Idiopathic Pulmonary Fibrosis IPF One-hundred- twenty patients will be enrolled in the trial in total Subjects must have a diagnosis made by HRCT showing definite or probable IPF and clinical symptoms consistent with IPF with onset between 3 and 36 months prior to screening Subjects will be randomly assigned to receive either Gleevec 600 mg orally or placebo once per day for approximately 2 years The primary efficacy will be progression defined as a greater than 10 decline in the forced vital capacity or death Measures of safety will include all randomized patients who receive at least one dose of study medication All adverse events and serious adverse events will be separately tabulated and mapped to a standard classification system and grouped by body system Any serious adverse events that occur during the trial and 30 days after the end of therapy will be reported to the FDA within 24 hours and followed to outcome
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