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| Sponsor: | Encysive Pharmaceuticals |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Encysive Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00039858 |
Purpose
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 |
|---|---|---|
|
Thrombocytopenia Thrombosis |
Drug: Argatroban |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin |
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria for Inclusion:
Criteria for Exclusion:
Contacts and Locations| 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 | |
| University of Chicago Children's Hospital | |
| Chicago, Illinois, United States, 60637 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00039858 History of Changes |
| Other Study ID Numbers: | ARG-401, SKF105043/013 |
| Study First Received: | June 13, 2002 |
| Last Updated: | January 10, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
heparin-induced thrombocytopenia heparin-induced thrombocytopenia and thrombosis HIT HITTS anticoagulation |
|
Thrombocytopenia Thrombosis Blood Platelet Disorders Hematologic Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Argatroban Anticoagulants Heparin Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Platelet Aggregation Inhibitors |