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Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices

This study has been completed.

Sponsored by: Nuvelo
Information provided by: Nuvelo
ClinicalTrials.gov Identifier: NCT00073515
  Purpose

This trial is for patients with a central venous catheter (a vascular access device) that is not functioning properly (unable to withdraw blood). The trial compares a new blood clot dissolving agent (alfimeprase) against the currently used treatment.


Condition Intervention Phase
Catheters, Indwelling
Drug: Alfimeprase
Phase II

Drug Information available for:   Alfimeprase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters

Further study details as provided by Nuvelo:

Estimated Enrollment:   115

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

Criteria

Subjects must:

  • have a dysfunctional Central Venous Access Device (CVAD) defined as unable to withdraw 3 mL blood
  • have had the device in place for > 48 hours
  • be clinically stable
  • be 18 or older
  • give informed consent
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073515

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

Sponsors and Collaborators
Nuvelo
  More Information


Alfimeprase Information  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   HA003, NuCath-1
First Received:   November 21, 2003
Last Updated:   February 16, 2007
ClinicalTrials.gov Identifier:   NCT00073515
Health Authority:   United States: Food and Drug Administration

Keywords provided by Nuvelo:
central venous access device  
thrombosis  
central venous catheter  
thrombolysis  
fibrinolysis  

Study placed in the following topic categories:
Thrombosis

ClinicalTrials.gov processed this record on November 30, 2008




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