Study Of Angiomax In Infants Under Six Months With Thromb... | NCT00043277

Studies
Study Of Angiomax In Infants Under Six Months With Thrombosis

NCT00043277

Sponsor

The Medicines Company

Status

Completed

Last Update Posted

Feb 1, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Thrombosis

Interventions

Angiomax (bivalirudin)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 2002

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Aug 7, 2002

First Submission Date that Met QC Criteria

Aug 7, 2002

First Posted Date

Aug 8, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2006

Last Update Posted Date

Feb 1, 2006Estimated

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Angiomax (bivalirudin)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guy Young, MD	Children's Hospital Orange County	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Orange County		Orange	California	92868	United States

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases