Intra-arterial Plasmin Study

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A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke.
 
Phase 1/2a, open-label, multi-center, sequential dose escalation, safety study of Plasmin (Human) in acute ischemic stroke caused by middle cerebral artery occlusion documented by arteriography. Plasmin (Human) will be administered through a catheter into the thrombus within 9 hours of stroke onset. A maximum of seventy-five (75) patients will receive Plasmin (Human), a maximum of twenty-five (25) patients at each of the 3 dose levels (20 mg, 40 mg, and 60 mg). The objectives of this study are to determine the safety and tolerability of Plasmin (Human), to select a dose for further testing, and to determine the proportion of patients with partial or full recanalization.

A total of 75 participants shall be recruited.

 

Last Updated ( Sunday, 17 October 2010 21:35 )