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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03826043 -
THrombo-Embolic Event in Onco-hematology
|
N/A | |
| Recruiting |
NCT04398628 -
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
|
||
| Completed |
NCT05426564 -
Exploratory Assessment of the Quantra® System in Adult ECMO Patients
|
||
| Not yet recruiting |
NCT05830916 -
Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis
|
||
| Recruiting |
NCT02972385 -
Pharmacogenomics of Warfarin in Hispanics and Latinos
|
||
| Completed |
NCT02917213 -
Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
|
||
| Completed |
NCT02526628 -
Thrombosis and Neurocognition in Klinefelter Syndrome
|
||
| Completed |
NCT02439190 -
CV004-007 Thrombosis Chamber Study
|
Phase 1 | |
| Completed |
NCT02341638 -
Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01855516 -
Partial Thromboplastin Time After 72 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin
|
N/A | |
| Unknown status |
NCT00983112 -
Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery
|
Phase 4 | |
| Completed |
NCT00412464 -
Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis
|
Phase 1 | |
| Completed |
NCT00479362 -
Anticoagulant Therapy During Pacemaker Implantation
|
Phase 4 | |
| Completed |
NCT00346424 -
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
|
Phase 3 | |
| Terminated |
NCT00303420 -
Alteplase for Blood Flow Restoration in Hemodialysis Catheters
|
Phase 4 | |
| Completed |
NCT00143715 -
Oral Vitamin K for Warfarin Associated Coagulopathy
|
Phase 3 | |
| Completed |
NCT00039858 -
Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
|
Phase 4 | |
| Completed |
NCT00007410 -
Genetic Architecture of Plasma T-PA and PAI-1
|
N/A | |
| Completed |
NCT00000538 -
Dietary Effects on Lipoproteins and Thrombogenic Activity
|
Phase 3 | |
| Completed |
NCT00005436 -
Lupus Cohort--Thrombotic Events and Coronary Artery Disease
|
N/A |