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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00039858
Recruitment Status : Completed
First Posted : June 14, 2002
Last Update Posted : January 11, 2007
Information provided by:
Encysive Pharmaceuticals

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
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 : September 2003
Study Completion Date : March 2006

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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00039858

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United States, California
Mattel Children's Hospital at UCLA
Los Angeles, California, United States, 90095
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Children's Hospital
Chicago, Illinois, United States, 60637
Children's Hospital of Illinois
Peoria, Illinois, United States, 61614
United States, Kentucky
Kosair Children's Hospital, University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Children's Hospital of Boston
Boston, Massachusetts, United States, 02115
United States, Michigan
Michigan Congenital Heart Center
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Rainbow Babies at Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Encysive Pharmaceuticals
Layout table for additonal information Identifier: NCT00039858    
Other Study ID Numbers: ARG-401
First Posted: June 14, 2002    Key Record Dates
Last Update Posted: January 11, 2007
Last Verified: January 2007
Keywords provided by Encysive Pharmaceuticals:
heparin-induced thrombocytopenia
heparin-induced thrombocytopenia and thrombosis
Additional relevant MeSH terms:
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Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors