NCT00043277

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (planned)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 0 Years – 6 Months
• Healthy volunteers: Not accepted

Summary

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).

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).

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	Angiomax (bivalirudin)

Timeline

• Start date: 2002-08-01
• Completion: 2004-12-01
• First posted: 2002-08-08
• Last updated: 2006-02-01

Locations

1 site across 1 country: United States