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Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

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: NCT00322270
Recruitment Status : Completed
First Posted : May 5, 2006
Last Update Posted : August 15, 2008
Sponsor:
Information provided by:
ARCA Biopharma, Inc.

Brief Summary:
To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central venous access device.

Condition or disease Intervention/treatment Phase
Thrombosis Venous Thrombosis Catheter Occlusion Drug: Alfimeprase Phase 3

Detailed Description:
Further study details as provided by Nuvelo

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3, Multicenter, Multinational, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects With Occluded Central Venous Access Devices (SONOMA-3)
Study Start Date : January 2006

Intervention Details:
  • Drug: Alfimeprase
    single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD


Primary Outcome Measures :
  1. Safety and efficacy [ Time Frame: up to120 minutes post study drug dosing ]

Secondary Outcome Measures :
  1. Adverse events, serious adverse events and bleeding events [ Time Frame: 24 hours post dosing ]
  2. Adverse events up to day 30 visit(day 28-45) after instillation of study drug [ Time Frame: approximately 28-45 days post dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must give written informed consent
  • Ages 18 or older
  • Unable to withdraw at least 3 mL of blood from a central venous access device
  • Hemodynamically stable
  • Available for follow-up assessments

Exclusion Criteria:

  • Inability to infuse at least 2 mL of saline through the catheter
  • Catheter placed less than 48 hours prior to detection of occlusion
  • Catheter used for hemodialysis or pheresis
  • Previous treatment with plasminogen activator for current episode of catheter occlusion
  • Less than 18 years of age
  • Any evidence of mechanical or nonthrombotic occlusion
  • In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
  • Increased risk for drug extravasation
  • Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g., intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
  • Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
  • Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
  • Any other subject feature that in the opinion of the investigator should preclude study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322270


Locations
Show Show 18 study locations
Sponsors and Collaborators
ARCA Biopharma, Inc.
Investigators
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Study Director: Susan Begelman, M.D. ARCA Biopharma, Inc.
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Responsible Party: Susan Begelman, MD, Director of Medical Sciences, Nuvelo, Inc.
ClinicalTrials.gov Identifier: NCT00322270    
Other Study ID Numbers: HA008
First Posted: May 5, 2006    Key Record Dates
Last Update Posted: August 15, 2008
Last Verified: August 2008
Keywords provided by ARCA Biopharma, Inc.:
Occluded Central Venous Access Devices
Occluded Catheters
Thrombosis
thrombosis, catheter
alfimeprase
thrombotic occlusion
thrombosis, CVAD
thrombosis, catheters
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases