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
  Purpose

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).

Condition Intervention Phase
Thrombosis
Drug: Angiomax (bivalirudin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Dose Finding And Efficacy Study Of Angiomax® (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

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

Estimated Enrollment: 25
Study Start Date: August 2002
Estimated Study Completion Date: December 2004
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).
  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043277

Locations
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
Sponsors and Collaborators
The Medicines Company
Investigators
Principal Investigator: Guy Young, MD Children's Hospital Orange County
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00043277     History of Changes
Other Study ID Numbers: TMC-BIV-02-04
Study First Received: August 7, 2002
Last Updated: January 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
neonates
thrombosis
bivalirudin
direct thrombin inhibitor

Additional relevant MeSH terms:
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Bivalirudin
Anticoagulants
Antithrombins
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014