Bivalirudin as a Procedural Anticoagulant in Pediatrics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00503126
First received: July 16, 2007
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

Pharmacokinetics and safety of weight based bivalirudin in children


Condition Intervention Phase
Cardiology
Drug: bivalirudin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bivalirudin (Angiomax®) As A Procedural Anticoagulant In The Pediatric Population Undergoing Intravascular Procedures For Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • PK/PD and safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bivalirudin
    anticoagulation
    Other Name: Angiomax/Angiox
  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and non-pregnant females, with an age range of birth to 16 years of age.
  • Expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease.
  • Written informed consent from a legal guardian/parent.
  • Life expectancy of at least 15 days at study entry.
  • Assent of the patient if older than 8 years, whenever possible.

Exclusion Criteria:

  • History of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit.
  • Gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles.
  • Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
  • Known congenital or acquired bleeding or clotting disorder.
  • Patients undergoing renal dialysis.*
  • Weight < 2.5 kg.
  • Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).
  • Known allergy to bivalirudin or hirudin-derived drugs, or known sensitivity to any component of bivalirudin (Angiomax®).
  • Any condition that in the investigator's opinion would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
  • Participation in another investigational therapeutic drug or therapeutic device trial within 30 days of starting study.
  • Patients who have been receiving warfarin (Coumadin®) therapy and whose INR is > 1.5.
  • Patients who cannot be discontinued from UFH at least 30 minutes prior to study drug bolus.
  • Patients who have received a dose of LMWH within 8 hours prior to study drug bolus.
  • Patients previously enrolled in the study.
  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.

No Contacts or Locations Provided
  More Information

No publications provided by The Medicines Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00503126     History of Changes
Other Study ID Numbers: TMC-BIV-07-01
Study First Received: July 16, 2007
Last Updated: November 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
pediatrics
bivalirudin

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

ClinicalTrials.gov processed this record on September 18, 2014