Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion - Full Text View

Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

This study has been completed.

Sponsors and Collaborators:	Nuvelo Health Decisions
Information provided by:	Nuvelo
ClinicalTrials.gov Identifier:	NCT00073554

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

MedlinePlus related topics:

Peripheral Arterial Disease Vascular Diseases

Drug Information available for:

Alfimeprase

U.S. FDA Resources

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 as provided by Nuvelo:

Estimated Enrollment:	100
Study Start Date:	June 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073554

Locations


United States, Ohio
	Cleveland Clinic Foundation
	Cleveland, Ohio, United States

Sponsors and Collaborators

Nuvelo

Health Decisions

More Information

Alfimeprase Information This link exits the ClinicalTrials.gov site

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
First Received:	November 24, 2003
Last Updated:	February 16, 2007
ClinicalTrials.gov Identifier:	NCT00073554
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases

Embolism and Thrombosis

Peripheral Vascular Diseases

Embolism

Vascular Diseases

Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008