Study Of Angiomax In Infants Under Six Months With Thrombosis

The Medicines Company

Status and phase

Completed

Phase 2

Conditions

Thrombosis

Treatments

Drug: Angiomax (bivalirudin)

Study type

Interventional

Funder types

Industry

Identifiers

TMC-BIV-02-04

Details and patient eligibility

About

The goals of this study are:

To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
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;
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).

Full description

The goals of this study are:

To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
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;
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).

Sex

All

Ages

Under 6 months old

Volunteers

No Healthy Volunteers

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