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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
History of Changes
  Purpose

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 Intervention Phase
Thrombosis
Venous Thrombosis
Catheter Occlusion
 Drug: Alfimeprase
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ARCA Biopharma, Inc.:

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

Secondary Outcome Measures:
  • 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 ]

Study Start Date: January 2006
Intervention Details:
    Drug: Alfimeprase
    single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
Detailed Description:

Further study details as provided by Nuvelo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322270

Locations
United States, Arizona
Desert Oasis Cancer Center
Casa Grande, Arizona, United States, 85222
United States, California
Cancer Research & Prevention Center
Soquel, California, United States, 95073
United States, Florida
Bethesda Research Center
Boynton Beach, Florida, United States, 33435
Pasco Hernando Oncology Associates
Brooksville, Florida, United States, 34613
Mercy Hospital
Miami, Florida, United States, 33133
Pasco Hernando Oncology Associate
New Port Richey, Florida, United States, 34652
United States, Illinois
Medical and Surgical Specialists
Galesburg, Illinois, United States, 61401
Cancer Center at Blessing Hospital
Quincy, Illinois, United States, 62301
United States, Michigan
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, United States, 49048
Sparrow Cancer Center
Lansing, Michigan, United States, 48912
United States, Missouri
Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States, 65109
The Center for Cancer Care and Research
St. Louis, Missouri, United States, 63141
United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, North Dakota
Dakota Cancer Institute
Fargo, North Dakota, United States, 58103
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Hematology/Oncology Consultants, Inc.
Columbus, Ohio, United States, 43235
United States, Texas
Texas Oncology, P.A.
Dallas, Texas, United States, 75230
United States, Virginia
Carilion Gynecology/Oncology
Roanoke, Virginia, United States, 24074
Sponsors and Collaborators
ARCA Biopharma, Inc.
Investigators
Study Director: Susan Begelman, M.D. ARCA Biopharma, Inc.
  More Information

No publications provided

Responsible Party: Susan Begelman, MD, Director of Medical Sciences, Nuvelo, Inc.
ClinicalTrials.gov Identifier: NCT00322270     History of Changes
Other Study ID Numbers: HA008
Study First Received: May 3, 2006
Last Updated: August 12, 2008
Health Authority: United States: Food and Drug Administration

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:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on May 22, 2013