Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion - Tabular View

Tracking Information
First Received Date ^ICMJE	November 24, 2003
Last Updated Date	February 16, 2007
Start Date ^ICMJE	June 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00073554 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion
Official Title ^ICMJE	A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients With Acute Peripheral Arterial Occlusion
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).
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Arterial Occlusive Diseases Peripheral Vascular Diseases Thrombosis
Intervention ^ICMJE	Drug: Alfimeprase
Study Arms / Comparison Groups
Publications *	Toombs CF. Alfimeprase: pharmacology of a novel fibrinolytic metalloproteinase for thrombolysis. Haemostasis. 2001 May-Dec;31(3-6):141-7. Review.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00073554
Responsible Party
Study ID Numbers ^ICMJE	HA002, NAPA-1
Study Sponsor ^ICMJE	ARCA Biopharma, Inc.
Collaborators ^ICMJE	Health Decisions
Investigators ^ICMJE
Information Provided By	ARCA Biopharma, Inc.
Verification Date	November 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP