drugset / Trial / NCT00418483
A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin doses to dissolve the clots will be estimated by arteriography.
Timeline
- Start
- 2007-03
- Primary completion
- 2010-04
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Plasmin | Protein / enzyme biologic | 25 mg | Other |
| Subject | Plasmin | Protein / enzyme biologic | 50 mg | Other |
| Subject | Plasmin | Protein / enzyme biologic | 75 mg | Other |
| Subject | Plasmin | Protein / enzyme biologic | 100 mg | Other |
| Subject | Plasmin | Protein / enzyme biologic | 125 mg | Other |
| Subject | Plasmin | Protein / enzyme biologic | 150 mg | Other |
| Subject | Plasmin | Protein / enzyme biologic | 175 mg | Other |