Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices

This study has been completed.

First Received on November 21, 2003. Last Updated on February 2, 2010 History of Changes

Sponsor:	ARCA Biopharma, Inc.
Information provided by:	ARCA Biopharma, Inc.
ClinicalTrials.gov Identifier:	NCT00073515

Purpose

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	Intervention	Phase
Catheters, Indwelling	Drug: Alfimeprase	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Drug Information available for: Alfimeprase

U.S. FDA Resources

Further study details as provided by ARCA Biopharma, Inc.:

Estimated Enrollment:

115

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073515

Locations

United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States

Sponsors and Collaborators

ARCA Biopharma, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00073515 History of Changes
Other Study ID Numbers:	HA003, NuCath-1
Study First Received:	November 21, 2003
Last Updated:	February 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by ARCA Biopharma, Inc.:

central venous access device
thrombosis
central venous catheter
thrombolysis
fibrinolysis

ClinicalTrials.gov processed this record on February 09, 2012