Bivalirudin as a Procedural Anticoagulant in Pediatrics

NCT00503126 | Completed Phase 2 DMC

• 1 other identifier: TMC-BIV-07-01
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pharmacokinetics and safety of weight based bivalirudin in children

Conditions

Cardiology

Keywords

pediatrics; bivalirudin

Outcome Measures

Primary Outcomes (1)

• PK/PD and safety

  30 days

Interventions

bivalirudin DRUG

anticoagulation

Also known as: Angiomax/Angiox

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Medicines Company: lead

Related Publications (1)

• Forbes TJ, Hijazi ZM, Young G, Ringewald JM, Aquino PM, Vincent RN, Qureshi AM, Rome JJ, Rhodes JF Jr, Jones TK, Moskowitz WB, Holzer RJ, Zamora R. Pediatric catheterization laboratory anticoagulation with bivalirudin. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):671-9. doi: 10.1002/ccd.22817. Epub 2011 Jan 4.

  PMID: 21433272 DERIVED

MeSH Terms

Interventions

bivalirudin

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 18, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 10, 2011

Record last verified: 2011-11