NCT01014975

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

A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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 groups of patients. Patients are monitored by imaging of the affected artery and functional testing.

Detailed description

This is a 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. Approximately sixty-one (61) patients will be enrolled and will receive Plasmin (Human). The objectives of this study are to determine the safety of escalating doses of Plasmin (Human) and to determine the proportion of patients with treatment success, defined as partial or full recanalization.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
BIOLOGICAL	Plasmin (Human)	Plasmin (Human), 20 mg, delivered through a catheter into a thrombus
BIOLOGICAL	Plasmin (Human)	Plasmin (Human), 40 mg, delivered through a catheter into a thrombus
BIOLOGICAL	Plasmin (Human)	Plasmin (Human), 80 mg, delivered through a catheter into a thrombus

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-11-01
• Completion: 2014-02-01
• First posted: 2009-11-17
• Last updated: 2015-10-21
• Results posted: 2015-10-21

Locations

23 sites across 6 countries: Australia, Austria, France, Serbia, Slovakia, Spain