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临床试验/jRCT2031230275
jRCT2031230275招募中不适用

Special Drug Use-Results Survey (All-Case Surveillance) to Investigate Safety and Effectiveness in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Received Empaveli in the Post-Marketing Clinical Use in Japan (PEG_PNH JPN PMS)

Swedish Orphan Biovitrum Japan Co., Ltd.0 个研究点目标入组 100 人开始时间: 2023年11月6日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
主要终点
Hypersensitivity

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
No limit 至 No limit(—)
性别
All

入选标准

  • All patients with PNH who received Empaveli in Japan from the date of product launch to 31 May 2028 or until the approval conditions are lifted.

排除标准

  • Not applicable.

结局指标

主要结局

Hypersensitivity

Occurrence of hypersensitivity adverse reactions

Meningococcal infection

Occurrence of meningococcal infection adverse reactions

Infections (except meningococci)

Occurrence of infections (except meningococci) adverse reactions

Serious hemolysis due to discontinuation of Empaveli

Occurrence of serious hemolysis due to discontinuation of Empaveli adverse reactions

次要结局

未报告次要终点

研究者

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