Study Of Angiomax In Infants Under Six Months With Thrombosis

This study has been completed.
Sponsor:
Information provided by:
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00043277
First received: August 7, 2002
Last updated: January 31, 2006
Last verified: January 2006

August 7, 2002
January 31, 2006
August 2002
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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.
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Complete list of historical versions of study NCT00043277 on ClinicalTrials.gov Archive Site
In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.
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Study Of Angiomax In Infants Under Six Months With Thrombosis
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).

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).
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thrombosis
Drug: Angiomax (bivalirudin)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2004
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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
Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00043277
TMC-BIV-02-04
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The Medicines Company
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Principal Investigator: Guy Young, MD Children's Hospital Orange County
The Medicines Company
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP