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

Thrombosis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

• NCT number: NCT00346424
• Study type: Interventional
• Source: ARCA Biopharma, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: September 2005
• Completion date: December 2006