Clinical Trial: Alfimeprase for thrombolysis in Acute Peripheral Arterial Occlusion


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Alfimeprase for thrombolysis in Acute Peripheral Arterial Occlusion

This study is currently recruiting patients.

Sponsored by:	Nuvelo Health Decisions
Information provided by:	Nuvelo

Purpose

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).

Condition	Treatment or Intervention	Phase
Arterial Occlusive Diseases Peripheral Vascular Diseases Thrombosis	Drug: Alfimeprase	Phase II

MedlinePlus related topics: Circulatory Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details:

Expected Total Enrollment: 100

Study start: June 2003

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

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

Location and Contact Information

Elia Borbas, RN 408-215-4511 eborbas@nuvelo.com
Luis Pena 408-215-4393 lpena@nuvelo.com

Ohio
Cleveland Clinic Foundation, Cleveland, Ohio, United States; Recruiting

Kenneth Ouriel, MD 216-445-3464

More Information

Alfimeprase Information

Publications

Toombs CF. Alfimeprase: pharmacology of a novel fibrinolytic metalloproteinase for thrombolysis. Haemostasis. 2001 May-Dec;31(3-6):141-7. Review.

Study ID Numbers: HA002; NAPA-1
Record last reviewed: November 2003
Record first received: November 24, 2003
ClinicalTrials.gov Identifier: NCT00073554
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09

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National Institutes of Health, Department of Health & Human Services