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Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

This study has been completed.
Sponsor:
Information provided by:
ARCA Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT00322270
First received: May 3, 2006
Last updated: August 12, 2008
Last verified: August 2008

May 3, 2006
August 12, 2008
January 2006
Not Provided
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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Thrombosis
  • Venous Thrombosis
  • Catheter Occlusion
Drug: Alfimeprase
single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00322270
HA008
No
Susan Begelman, MD, Director of Medical Sciences, Nuvelo, Inc.
ARCA Biopharma, Inc.
Not Provided
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