Thrombosis Clinical Trial
Official title:
A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients With Acute Peripheral Arterial Occlusion
| Verified date | November 2006 |
| Source | ARCA Biopharma, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
- Patients with acute peripheral arterial occlusion of the lower limb (onset of
symptoms within 14 days) - Rutherford Class I or IIa (minimal sensory loss, no muscle weakness, audible venous flow) - Age 18 or above - Able to consent - Able to follow up |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| ARCA Biopharma, Inc. | Health Decisions |
United States,
Toombs CF. Alfimeprase: pharmacology of a novel fibrinolytic metalloproteinase for thrombolysis. Haemostasis. 2001 May-Dec;31(3-6):141-7. Review. — View Citation
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