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

February 2, 2010 updated by: ARCA Biopharma, Inc.

A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

115

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCA Biopharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 21, 2003

First Submitted That Met QC Criteria

November 24, 2003

First Posted (Estimate)

November 25, 2003

Study Record Updates

Last Update Posted (Estimate)

February 3, 2010

Last Update Submitted That Met QC Criteria

February 2, 2010

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HA003
  • NuCath-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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