Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|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|
- Catheter function restoration at fifteen minutes after initial instillation of study drug. [ Time Frame: 15 minutes ]
- Catheter function restoration at 30 minutes after initial instillation of study drug. [ Time Frame: 30 minutes ]
- Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose. [ Time Frame: additional 30 minutes ]
|Study Start Date:||September 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
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.
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.
- Adverse events
- Major bleeding events
- Change in laboratory values.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346424
|United States, Oregon|
|Corvallis, Oregon, United States, 97330|
|Study Director:||Steven Deitcher, M.D.||ARCA Biopharma, Inc.|