Study Of Angiomax In Infants Under Six Months With Thrombosis - Full Text View

Sponsored by:	The Medicines Company
Information provided by:	The Medicines Company
ClinicalTrials.gov Identifier:	NCT00043277

Purpose

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).

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

MedlinePlus related topics: Blood Thinners

Drug Information available for: Bivalirudin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Dose Finding And Efficacy Study Of Angiomax® (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis

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:

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).

Eligibility

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

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

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

Keywords provided by The Medicines Company:

neonates
thrombosis
bivalirudin
direct thrombin inhibitor

Study placed in the following topic categories:

Thrombin
Signs and Symptoms
Embolism and Thrombosis
Embolism

Bivalirudin
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009