Study Of Angiomax In Infants Under Six Months With Thrombosis

January 31, 2006 updated by: The Medicines Company

Pilot Dose Finding And Efficacy Study Of Angiomax® (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis

The goals of this study are:

  1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
  2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
  3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goals of this study are:

  1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
  2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
  3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

Study Type

Interventional

Enrollment

25

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
    • California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County

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

1 second to 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parent/legal-guardian has provided written informed consent before initiation of any study related procedures.
  • Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram.
  • Age less than 6 months .
  • Gestational age greater than 35 weeks
  • Expected life expectancy at least 14 days.
  • No contraindication to anticoagulation i.e. bleeding complications.

Exclusion Criteria:

  • Active or recent (less than 7 days) bleeding.
  • Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product.
  • Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
  • Refusal to undergo blood transfusion should it become necessary.
  • Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the trial.
  • Baseline prolonged PT (>18 secs) or aPTT (>55 secs)
  • Platelet count < 50,000 cells/mm3
  • Birth Trauma
  • Planned or indicated surgery within 30 days
  • Major or minor bleeding event

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.

Secondary Outcome Measures

Outcome Measure
In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.

Collaborators and Investigators

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

Sponsor

The Medicines Company

Investigators

  • Principal Investigator: Guy Young, MD, Children's Hospital Orange County

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

August 1, 2002

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

August 7, 2002

First Submitted That Met QC Criteria

August 7, 2002

First Posted (ESTIMATE)

August 8, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2006

Last Update Submitted That Met QC Criteria

January 31, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMC-BIV-02-04

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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