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ギラン・バレー症候群患者を対象としたNPB-01の第III相臨床試験

基本情報

NCT ID
NCT02221271
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
22
治験依頼者名
Nihon Pharmaceutical Co., Ltd

概要

Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Patients evaluate the Functional Grade(FG) and Arm Grade(AG) et al. As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by the start of the study treatment.

対象疾患

Guillain-Barré Syndrome

介入

NPB-01(DRUG)

依頼者(Sponsor)

Nihon(INDUSTRY)

実施施設 (1)

Nihon Pharmaceutical Co., Ltd

Osaka, Japan