Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
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|ClinicalTrials.gov Identifier: NCT00346424|
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : August 14, 2008
|Condition or disease||Intervention/treatment||Phase|
|Thrombosis Venous Thrombosis||Drug: Alfimeprase||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||December 2006|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346424
|United States, Oregon|
|Corvallis, Oregon, United States, 97330|
|Study Director:||Steven Deitcher, M.D.||ARCA Biopharma, Inc.|