A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction

Completed · Phase 1/Phase 2

Conditions studied: Acute Myocardial Infarction

In brief

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 2:1 randomization with 9 patients total. Filgrastim 10 mcg/kg/day 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 mcg/kg/day.

Key facts

Study ID
NCT00215124
Run by
The Cleveland Clinic
Expected to finish
2007-02-01
Last updated by the study team
2008-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Where it is running

Full record on ClinicalTrials.gov

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