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Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00073554
Recruitment Status : Completed
First Posted : November 26, 2003
Last Update Posted : December 17, 2009
Sponsor:
Collaborator:
Health Decisions
Information provided by:
ARCA Biopharma, Inc.

Tracking Information
First Submitted Date  ICMJE November 24, 2003
First Posted Date  ICMJE November 26, 2003
Last Update Posted Date December 17, 2009
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Arterial Occlusive Diseases
  • Peripheral Vascular Diseases
  • Thrombosis
Intervention  ICMJE Drug: Alfimeprase
Study Arms  ICMJE Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00073554
Other Study ID Numbers  ICMJE HA002
NAPA-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE ARCA Biopharma, Inc.
Collaborators  ICMJE Health Decisions
Investigators  ICMJE Not Provided
PRS Account 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