Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215124
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2005-09-14
Brief Title:
A Phase I - II Safety Study of Filgrastim Neupogen to Improve Left Ventricular Function After Severe Acute Myocardial Infarction
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Phase I - II Safety Study of Filgrastim Neupogen to Improve Left Ventricular Function After Severe Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to obtain initial information regarding the safety and efficacy of the use of Filgrastim in the setting of acute myocardial infarction
The secondary objectives are to obtain information regarding the mobilization of relevant stem cell progenitor cells by Filgrastim in this setting and to obtain further clinical information that may be helpful in the assessment of safety and efficacy of this drug as utilized
It is a one center randomized placebo controlled dose escalation blinded study It will be 21 randomization with 9 patients total
Filgrastim 10 mcgkgday will be administered SQ for 5 days vs placebo
Primary endpoint is death or myocardial rupture or change in left ventricular ejection fraction from baseline to 30 days
9 pts have already completed the first phase of the trial using Filgrastim 5 mcgkgday
The secondary objectives are to obtain information regarding the mobilization of relevant stem cell progenitor cells by Filgrastim in this setting and to obtain further clinical information that may be helpful in the assessment of safety and efficacy of this drug as utilized
It is a one center randomized placebo controlled dose escalation blinded study It will be 21 randomization with 9 patients total
Filgrastim 10 mcgkgday will be administered SQ for 5 days vs placebo
Primary endpoint is death or myocardial rupture or change in left ventricular ejection fraction from baseline to 30 days
9 pts have already completed the first phase of the trial using Filgrastim 5 mcgkgday
Detailed Description:
None
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