Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin

Sponsor

Encysive Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00039858

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Locations

Duration (Months)

1.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopenia Thrombosis	Drug: Argatroban	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin

Study Start Date :

Sep 1, 2003

Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Criteria for Inclusion:

Males and females ages birth to 16 years,inclusive, at enrollment. For neonates, the minimum corrected gestational age should be 37 weeks.
Documented HIT defined as a fall in platelet count to less than 100,000/uL or a >=50% decrease in platelets after the initiation of heparin therapy with no apparent explanation other than HIT, or
Require anticoagulation and have a documented history of a positive HIT test in the absence of current thrombocytopenia (i.e. patients at risk for HIT), or
In the opinion of the investigator, require alternative anticoagulation due to an underlying condition, such as AT-III deficiency or heparin resistance.
Signed (written) informed consent or assent by the patient (if age appropriate) and the patient's parent or guardian.

Criteria for Exclusion:

Any condition which, in the investigator's opinion, would contraindicate the use of Argatroban or would endanger the patient if he/she participated in this trial.
Unexplained aPTT > 2 times the upper limit of normal at baseline, in the absence of heparin.
International Normalized Ratio (INR) >1.6 at baseline in the absence of warfarin.
Known clinical site of bleeding or predisposition to bleeding (e.g., GI bleed, hematuria, hemorrhagic CVA,retroperitoneal hematoma, diabetic retinopathy, hemorrhagic pericardial effusion, or hemorrhagic pleural effusion. Patients who have a known clinical site of bleeding may be enrolled if the investigator deems the risk of continued thrombosis to outweigh the potential bleeding risk.
Any patient who has received any investigational medication within 30 days prior to the first dose of study medication or who is scheduled to receive an investigational drug other than Argatroban during the course of the study.
Known hypersensitivity to Argatroban or chemically related compounds.
Females of childbearing potential who are pregnant (positive serum beta-HCG), breast feeding, or sexually active and not taking adequate contraceptive precautions (e.g. IUD or oral contraceptives).
Any patient receiving a thrombolytic medication (e.g. tPA).
Any neonate with a corrected gestational age of < or = 44 weeks and bleeding in the head (Grade I or above) as determined by head ultrasound.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mattel Children's Hospital at UCLA	Los Angeles	California	United States	90095
2	Children's Hospital of Orange County	Orange	California	United States	92868
3	Rush University Medical Center	Chicago	Illinois	United States	60612
4	University of Chicago Children's Hospital	Chicago	Illinois	United States	60637
5	Children's Hospital of Illinois	Peoria	Illinois	United States	61614
6	Kosair Children's Hospital, University of Louisville	Louisville	Kentucky	United States	40202
7	Children's Hospital of Boston	Boston	Massachusetts	United States	02115
8	Michigan Congenital Heart Center	Ann Arbor	Michigan	United States	48109
9	Rainbow Babies at Children's Hospital	Cleveland	Ohio	United States	44106
10	Oregon Health & Science University	Portland	Oregon	United States	97201
11	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
12	Primary Children's Medical Center	Salt Lake City	Utah	United States	84113
13	Children's Hospital and Regional Medical Center	Seattle	Washington	United States	98105