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)
1 other identifier
interventional
N/A
1 country
18
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.
Trial Health
Trial Health Score
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18 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 3, 2006
CompletedFirst Posted
Study publicly available on registry
May 5, 2006
CompletedAugust 15, 2008
August 1, 2008
May 3, 2006
August 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and efficacy
up to120 minutes post study drug dosing
Secondary Outcomes (2)
Adverse events, serious adverse events and bleeding events
24 hours post dosing
Adverse events up to day 30 visit(day 28-45) after instillation of study drug
approximately 28-45 days post dosing
Interventions
single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Desert Oasis Cancer Center
Casa Grande, Arizona, 85222, United States
Cancer Research & Prevention Center
Soquel, California, 95073, United States
Bethesda Research Center
Boynton Beach, Florida, 33435, United States
Pasco Hernando Oncology Associates
Brooksville, Florida, 34613, United States
Mercy Hospital
Miami, Florida, 33133, United States
Pasco Hernando Oncology Associate
New Port Richey, Florida, 34652, United States
Medical and Surgical Specialists
Galesburg, Illinois, 61401, United States
Cancer Center at Blessing Hospital
Quincy, Illinois, 62301, United States
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, 49048, United States
Sparrow Cancer Center
Lansing, Michigan, 48912, United States
Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109, United States
The Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
Dakota Cancer Institute
Fargo, North Dakota, 58103, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Hematology/Oncology Consultants, Inc.
Columbus, Ohio, 43235, United States
Texas Oncology, P.A.
Dallas, Texas, 75230, United States
Carilion Gynecology/Oncology
Roanoke, Virginia, 24074, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Susan Begelman, M.D.
ARCA Biopharma, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 3, 2006
First Posted
May 5, 2006
Study Start
January 1, 2006
Last Updated
August 15, 2008
Record last verified: 2008-08