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

May 3, 2006
May 5, 2006
August 15, 2008
January 2006
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Safety and efficacy [ Time Frame: up to120 minutes post study drug dosing ]
Safety for up to 120 minutes after instillation of the final dose of study drug.
Complete list of historical versions of study NCT00322270 on Archive Site
  • Adverse events, serious adverse events and bleeding events [ Time Frame: 24 hours post dosing ]
  • Adverse events up to day 30 visit(day 28-45) after instillation of study drug [ Time Frame: approximately 28-45 days post dosing ]
  • Adverse events at 8-24 hours after instillation of first study drug dose in the first 200 enrolled subjects
  • Adverse events at day 30 (day 28-45) after instillation of first study drug dose
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Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters
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)
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.
Further study details as provided by Nuvelo
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Thrombosis
  • Venous Thrombosis
  • Catheter Occlusion
Drug: Alfimeprase
single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Susan Begelman, MD, Director of Medical Sciences, Nuvelo, Inc.
ARCA Biopharma, Inc.
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Study Director: Susan Begelman, M.D. ARCA Biopharma, Inc.
ARCA Biopharma, Inc.
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP