NCT00346424

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

Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Occluded Central Venous Access Devices

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: ARCA Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Outcomes: The ability to withdraw at least 3 ml of blood and infuse more at least 5 mL of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation of study drug. Secondary Outcomes: The ability to withdraw at least 3 mL of blood and infuse at least 5 mL of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation. Safety: * Adverse events * Major bleeding events * Change in laboratory values.

Conditions

• Thrombosis
• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Alfimeprase

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-10-01
• Completion: 2006-12-01
• First posted: 2006-06-30
• Last updated: 2008-08-14

Locations

1 site across 1 country: United States