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

Tracking Information

First Received Date ^ICMJE

August 7, 2002

Last Updated Date

January 31, 2006

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00043277 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study Of Angiomax In Infants Under Six Months With Thrombosis

Official Title ^ICMJE

Pilot Dose Finding And Efficacy Study Of Angiomax® (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis

Brief Summary

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).

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).

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Thrombosis

Intervention ^ICMJE

Drug: Angiomax (bivalirudin)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 6 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00043277

Responsible Party

Study ID Numbers ^ICMJE

TMC-BIV-02-04

Study Sponsor ^ICMJE

The Medicines Company

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Guy Young, MD

Children's Hospital Orange County

Information Provided By

The Medicines Company

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP