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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCA Biopharma, Inc.

Criteria

Inclusion Criteria:

• 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

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 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