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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