Status:
COMPLETED
Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Heparin-induced Thrombocytopenia Type II
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombos...
Eligibility Criteria
Inclusion
- Subjects aged \>= 18 years
- Females of child bearing potential must have a negative urine pregnancy test prior to entry into the study
- Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral anticoagulation
- Signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative
Exclusion
- Uncontrolled bleeding
- Severe hepatic impairment (Child-Pugh Class C)
- Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol)
- Pregnancy (exclusion by routine urine test)
- Lactating woman
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00861692
Start Date
April 1 2009
End Date
February 1 2011
Last Update
January 6 2026
Active Locations (1)
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1
Saint-Etienne, France