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| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 13, 2002 |
| Last Updated Date | January 10, 2007 |
| Start Date ICMJE | September 2003 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00039858 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin |
| Official Title ICMJE | Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin |
| 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. |
| Detailed Description | |
| Study Phase | Phase IV |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Argatroban |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 24 |
| Completion Date | March 2006 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Criteria for Inclusion:
Criteria for Exclusion:
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| Gender | Both |
| Ages | up to 16 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00039858 |
| Responsible Party | |
| Study ID Numbers ICMJE | ARG-401, SKF105043/013 |
| Study Sponsor ICMJE | Encysive Pharmaceuticals |
| Collaborators ICMJE | GlaxoSmithKline |
| Investigators ICMJE | |
| Information Provided By | Encysive Pharmaceuticals |
| Verification Date | January 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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