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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 2

Conditions: Heparin-induced Thrombocytopenia Type II

Treatments: Drug: argatroban

Study type: Interventional

Funder types: Industry

Identifiers

NCT00861692

ARG-E07

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Argatroban

Experimental group

Treatment:

Drug: argatroban