DRKS00025479招募中不适用
Analysis/Outcomes of Patients who switched from being under eculizumab to ravulizumab treatment in a real-world setting – according to the label but not included in Phase 3 studies - RavuReWo
Alexion Pharma Deutschland GmbH0 个研究点目标入组 30 人开始时间: 2021年10月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patient is = 18 years at time of switch to ravulizumab
- •Diagnosis of PNH established by flow cytometry
- •Patient was pretreated with eculizumab and data from treatment with eculizumab are available
- •Willingness to participate in the study and provide written informed consent
- •Participant is currently receiving or starting treatment with ravulizumab treatment in accordance with the SmPC
- •Patient experienced HDA within 6 months of eculizumab treatment prior to switch to ravulizumab, with HDA defined as hemolysis (LDH = 1.5 x ULN) in combination with = 1 of the following PNH symptoms:
- •oHemoglobinuria
- •oAbdominal pain
- •oAnemia [< 10 g/dl],
- •oMAVEc [including thrombosis],
- •oErectile dysfunction
- •oPNH related transfusion
排除标准
- •Unwillingness / anticipated inability to attend further visits
- •Off-label treatment with ravulizumab
研究者
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