drugset / Trial / NCT01014975
A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-11
- Primary completion
- 2013-11
- Completion
- 2014-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Plasmin | Protein / enzyme biologic | 20 mg | Other |
| Subject | Plasmin | Protein / enzyme biologic | 40 mg | Other |
| Subject | Plasmin | Protein / enzyme biologic | 80 mg | Other |