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Sponsors and Collaborators: |
Encysive Pharmaceuticals GlaxoSmithKline |
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Information provided by: | Encysive Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00039858 |
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 | Intervention | Phase |
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Thrombocytopenia Thrombosis |
Drug: Argatroban |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin |
Ages Eligible for Study: | up to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria for Inclusion:
Criteria for Exclusion:
United States, California | |
Children's Hospital of Orange County | |
Orange, California, United States, 92868 | |
Mattel Children's Hospital at UCLA | |
Los Angeles, California, United States, 90095 | |
United States, Illinois | |
Children's Hospital of Illinois | |
Peoria, Illinois, United States, 61614 | |
University of Chicago Children's Hospital | |
Chicago, Illinois, United States, 60637 | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
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 |
Study ID Numbers: | ARG-401, SKF105043/013 |
Study First Received: | June 13, 2002 |
Last Updated: | January 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00039858 History of Changes |
Health Authority: | United States: Food and Drug Administration |
heparin-induced thrombocytopenia heparin-induced thrombocytopenia and thrombosis HIT HITTS anticoagulation |
Anticoagulants Hematologic Diseases Heparin Induced Thrombocytopenia Blood Platelet Disorders Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Thrombosis Calcium heparin |
Thrombocytopathy Fibrin Modulating Agents Embolism and Thrombosis Thrombocytopenia Argatroban Embolism Platelet Aggregation Inhibitors Heparin |
Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Diseases Blood Platelet Disorders Hematologic Agents Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Thrombosis |
Pharmacologic Actions Fibrin Modulating Agents Embolism and Thrombosis Thrombocytopenia Argatroban Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Heparin |