Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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 thrombosis who require parenteral antithrombotic therapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Argatroban; Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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