門脈血栓症患者におけるNPB-06のプラセボ対照試験

基本情報

NCT ID

NCT02250391

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

72

治験依頼者名

Nihon Pharmaceutical Co., Ltd

概要

Patients with portal vein thrombosis, who have chronic liver diseases especially liver cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06 or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis. The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and 21 days after administration in comparison with the placebo group.

対象疾患

介入

依頼者（Sponsor）