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.

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT00322270

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.
Study Director: Susan Begelman, M.D. ARCA Biopharma, Inc.

Responsible Party: Susan Begelman, MD, Director of Medical Sciences, Nuvelo, Inc. Identifier: NCT00322270     History of Changes
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, catheter
thrombotic occlusion
thrombosis, CVAD
thrombosis, catheters

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases