Back to resultsAlfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion
Primary Purpose
Arterial Occlusive Diseases, Peripheral Vascular Diseases, Thrombosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alfimeprase
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Occlusive Diseases
Eligibility Criteria
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
Sites / Locations
- Cleveland Clinic Foundation
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00073554
First Posted
November 24, 2003
Last Updated
December 16, 2009
Sponsor
ARCA Biopharma, Inc.
Collaborators
Health Decisions
1. Study Identification
Unique Protocol Identification Number
NCT00073554
Brief Title
Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
ARCA Biopharma, Inc.
Collaborators
Health Decisions
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Diseases, Peripheral Vascular Diseases, Thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alfimeprase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11910179
Citation
Toombs CF. Alfimeprase: pharmacology of a novel fibrinolytic metalloproteinase for thrombolysis. Haemostasis. 2001 May-Dec;31(3-6):141-7. doi: 10.1159/000048057.
Results Reference
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Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion
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