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Home > "E" Clinical Trials Conditions > Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin  Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
For Condition: Thrombosis,Thrombocytopenia
Status: Recruiting
Sponsor(s): GlaxoSmithKline and Encysive Pharmaceuticals Inc. ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /16 Years
Genders: Both
Protocol Entry Criteria: Basic Inclusion Criteria: - Males and females ages birth - 16 years. - Documented heparin-induced thrombocytopenia (HIT) - Require anticoagulation with documented histories of positive HIT antibody test - In the opinion of the investigator require alternative anticoagulation due to an underlying condition. - Negative pregnancy test. Basic Exclusion Criteria: - Unexplained aPTT > 2 times the upper limit of normal at baseline - INR >1.6 times the upper limit of normal at baseline - Documented bleeding diathesis unrelated to HIT - Known clinical site of bleeding (e.g., GI bleed, hematuria, hemorrhagic CVA, etc.). Patients with a known clinical site of bleeding may be enrolled if the risk of thrombosis outweighs the potential bleeding risk. - Any patient who has received any invesitgational 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 related compounds. - Any condition which, in the opinion of the doctor, would contraindicate the use of Argatroban or would endanger the patient if he/she participated.
Total Enrollment: 24
Location and Contact Information:
Oregon Health & Science University *Recruiting*
Portland, Oregon, 97201
United States
Recruiting Lynn Boshkov
University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Madelyn Kahana
Children's Hospital of Orange County *Recruiting*
Orange, California, 92868
United States
Recruiting Guy Young
Additional Information:
Study ID Numbers: ARG-401; SKF105043/013
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039858
Other Thrombosis Studies:
1. Alfimeprase for thrombolysis in Acute Peripheral Arterial Occlusion
2. Genetic Architecture of Plasma T-PA and PAI-1
3. Inflammation Markers Over Time in Cardiovascular Disease
4. Dose Finding And Efficacy Study Of Angiomax In Infants Under Six Months With Thrombosis
5. Inflammation Genomics and Atherosclerosis - Ancillary to CARDIA
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Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
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