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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Further study details as provided by Nuvelo

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCA Biopharma, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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