Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

Completed · Phase 3

Conditions studied: Thrombosis, Venous Thrombosis, Catheter Occlusion

In brief

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.

Key facts

Study ID

NCT00322270

Run by

ARCA Biopharma, Inc.

Starts

2006-01-01

Last updated by the study team

2008-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Desert Oasis Cancer Center — Casa Grande, Arizona, United States
• Cancer Research & Prevention Center — Soquel, California, United States
• Bethesda Research Center — Boynton Beach, Florida, United States
• Pasco Hernando Oncology Associates — Brooksville, Florida, United States
• Mercy Hospital — Miami, Florida, United States
• Pasco Hernando Oncology Associate — New Port Richey, Florida, United States
• Medical and Surgical Specialists — Galesburg, Illinois, United States
• Cancer Center at Blessing Hospital — Quincy, Illinois, United States
• Kalamazoo Hematology and Oncology — Kalamazoo, Michigan, United States
• Sparrow Cancer Center — Lansing, Michigan, United States
• Comprehensive Cancer Care Clinic — Jefferson City, Missouri, United States
• The Center for Cancer Care and Research — St Louis, Missouri, United States
• UMDNJ-Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Dakota Cancer Institute — Fargo, North Dakota, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Hematology/Oncology Consultants, Inc. — Columbus, Ohio, United States
• Texas Oncology, P.A. — Dallas, Texas, United States
• Carilion Gynecology/Oncology — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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