Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices
Sponsor
ARCA Biopharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00073515
Collaborator
(none)
115
1
Study Details
Study Description
Brief Summary
This trial is for patients with a central venous catheter (a vascular access device) that is not functioning properly (unable to withdraw blood). The trial compares a new blood clot dissolving agent (alfimeprase) against the currently used treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Subjects must:
-
have a dysfunctional Central Venous Access Device (CVAD) defined as unable to withdraw 3 mL blood
-
have had the device in place for > 48 hours
-
be clinically stable
-
be 18 or older
-
give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic Foundation | Cleveland | Ohio | United States |
Sponsors and Collaborators
- ARCA Biopharma, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00073515
Other Study ID Numbers:
- HA003
- NuCath-1
First Posted:
Nov 25, 2003
Last Update Posted:
Feb 3, 2010
Last Verified:
Jun 1, 2005
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