Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters

August 12, 2008 updated by: ARCA Biopharma, Inc.

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

The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Secondary Outcomes:

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.

Safety:

  • Adverse events
  • Major bleeding events
  • Change in laboratory values.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

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
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Corvallis Clinic

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

Inclusion Criteria:

  • Must give written informed consent
  • Unable to withdraw 3 mL of blood from a central venous access device
  • Hemodynamically stable
  • Available for follow-up assessments

Exclusion Criteria:

  • Inability to infuse at least 2 mL of saline through the catheter
  • Catheter placed less than 48 hours prior to detection of occlusion
  • Catheter used for hemodialysis of pheresis
  • Less than 18 years of age
  • Evidence of mechanical or nonthrombotic occlusion
  • Receipt of any thrombolytic agent within 24 hours of randomization
  • In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
  • Increased risk for drug extravasation
  • Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
  • Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
  • Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
  • Any other subject feature that in the opinion of the investigator should preclude study participation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Catheter function restoration at fifteen minutes after initial instillation of study drug.
Time Frame: 15 minutes
15 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Catheter function restoration at 30 minutes after initial instillation of study drug.
Time Frame: 30 minutes
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
additional 30 minutes

Collaborators and Investigators

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

Sponsor

ARCA Biopharma, Inc.

Investigators

  • Study Director: Steven Deitcher, M.D., 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 Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

June 28, 2006

First Submitted That Met QC Criteria

June 29, 2006

First Posted (Estimate)

June 30, 2006

Study Record Updates

Last Update Posted (Estimate)

August 14, 2008

Last Update Submitted That Met QC Criteria

August 12, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA006

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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