Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices - Full Text View

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

This study has been completed.

Sponsored by:	Nuvelo
Information provided by:	Nuvelo
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

Drug Information available for:

Alfimeprase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Nuvelo:

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

Nuvelo

More Information

Alfimeprase Information This link exits the ClinicalTrials.gov site

Study ID Numbers:	HA003, NuCath-1
First Received:	November 21, 2003
Last Updated:	February 16, 2007
ClinicalTrials.gov Identifier:	NCT00073515
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nuvelo:

central venous access device

thrombosis

central venous catheter

thrombolysis

fibrinolysis

Study placed in the following topic categories:

Thrombosis

ClinicalTrials.gov processed this record on November 30, 2008