Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

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

Phase 3, Multicenter, Multinational, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects With Occluded Central Venous Access Devices (SONOMA-3)

To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central venous access device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Further study details as provided by Nuvelo

Study Type

Interventional

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
    • Arizona
      • Casa Grande, Arizona, United States, 85222
        • Desert Oasis Cancer Center
    • California
      • Soquel, California, United States, 95073
        • Cancer Research & Prevention Center
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Bethesda Research Center
      • Brooksville, Florida, United States, 34613
        • Pasco Hernando Oncology Associates
      • Miami, Florida, United States, 33133
        • Mercy Hospital
      • New Port Richey, Florida, United States, 34652
        • Pasco Hernando Oncology Associate
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Medical and Surgical Specialists
      • Quincy, Illinois, United States, 62301
        • Cancer Center at Blessing Hospital
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Kalamazoo Hematology and Oncology
      • Lansing, Michigan, United States, 48912
        • Sparrow Cancer Center
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Comprehensive Cancer Care Clinic
      • St. Louis, Missouri, United States, 63141
        • The Center for Cancer Care and Research
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • UMDNJ-Robert Wood Johnson Medical School
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Dakota Cancer Institute
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Columbus, Ohio, United States, 43235
        • Hematology/Oncology Consultants, Inc.
    • Texas
      • Dallas, Texas, United States, 75230
        • Texas Oncology, P.A.
    • Virginia
      • Roanoke, Virginia, United States, 24074
        • Carilion Gynecology/Oncology

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
  • Ages 18 or older
  • Unable to withdraw at least 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 or pheresis
  • Previous treatment with plasminogen activator for current episode of catheter occlusion
  • Less than 18 years of age
  • Any evidence of mechanical or nonthrombotic occlusion
  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and efficacy
Time Frame: up to120 minutes post study drug dosing
up to120 minutes post study drug dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, serious adverse events and bleeding events
Time Frame: 24 hours post dosing
24 hours post dosing
Adverse events up to day 30 visit(day 28-45) after instillation of study drug
Time Frame: approximately 28-45 days post dosing
approximately 28-45 days post dosing

Collaborators and Investigators

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

Sponsor

ARCA Biopharma, Inc.

Investigators

  • Study Director: Susan Begelman, 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

January 1, 2006

Study Registration Dates

First Submitted

May 3, 2006

First Submitted That Met QC Criteria

May 3, 2006

First Posted (Estimate)

May 5, 2006

Study Record Updates

Last Update Posted (Estimate)

August 15, 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

  • HA008

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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