NCT00198588

Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia

Open-Label Trial to Evaluate the Efficacy and Safety of the Use of Argatroban in Patients With Heparin-Induced Thrombocytopenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ministry of Health, Labour and Welfare, Japan · Other Government
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate efficacy and safety of argatroban in the patients with heparin-induced thrombocytopenia (HIT)/ HIT and thrombosis syndrome (HITTS). This multi-center trial covers mainly the patients with cardiovascular diseases. Subjects are included in the trial when they are clinically diagnosed of HIT/HITTS. Initial dose of argatroban is 0.7μg/kg/min, which is about one-third of the approved dose in the US. The reason of the lower initial dose is that the approved dose of argatroban in Japan (for the treatment of ischemic stroke) is about 0.7μg/kg/min and safety of higher doses of the drug are not confirmed. A sub-study of pharmacokinetics is simultaneously conducted to reveal the relationship among the dose, aPTT, and blood drug concentration.

Conditions

• Heparin-Induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	argatroban	beginning dose: 0.7microgram/kg/H

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-07-01
• Completion: 2006-09-01
• First posted: 2005-09-20
• Last updated: 2008-11-13

Locations

20 sites across 1 country: Japan