NCT00322270

Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

Phase 3, Multicenter, Multinational, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects With Occluded Central Venous Access Devices (SONOMA-3)

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

Summary

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.

Detailed description

Further study details as provided by Nuvelo

Conditions

• Thrombosis
• Venous Thrombosis
• Catheter Occlusion

Interventions

Type	Name	Description
DRUG	Alfimeprase	single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD

Timeline

• Start date: 2006-01-01
• First posted: 2006-05-05
• Last updated: 2008-08-15

Locations

18 sites across 1 country: United States