ヘパリン誘発性血小板減少症の治療におけるアルガトロバンの有効性および安全性に関する研究

基本情報

NCT ID

NCT00198588

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

8

治験依頼者名

Ministry of Health, Labour and Welfare, Japan

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (20)