A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

Completed

Phase 1/2 Results

Summary of Purpose

This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different...

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 22 September 2015.

1 Nov 2009 16 Nov 2009 1 Nov 2013 1 Feb 2014 1 Sep 2015 20 Aug 2015
Start Date First Received 1st Completion Completion Verification Results

Trial Basics

Interventions

Conditions

Sponsors

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Contacts