Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters

Completed · Phase 3

Conditions studied: Thrombosis, Venous Thrombosis

In brief

The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.

Key facts

Study ID

NCT00346424

Run by

ARCA Biopharma, Inc.

People needed

300

Starts

2005-09-01

Expected to finish

2006-12-01

Last updated by the study team

2008-08-14

Who can join

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

You may qualify if…

• Must give written informed consent
• Unable to withdraw 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 of pheresis
• Less than 18 years of age
• Evidence of mechanical or nonthrombotic occlusion
• Receipt of any thrombolytic agent within 24 hours of randomization
• 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

• Corvallis Clinic — Corvallis, Oregon, United States

Full record on ClinicalTrials.gov

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