NCT07413679进行中（未招募）不适用
An Observational Study to Assess Long-Term Safety of Danicopan Add-on Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria: Analysis of IPIG-Registry Data
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants with Serious Adverse Events (SAEs)
研究概览
简要总结
This is a noninterventional cohort study using primary and secondary data from the International PNH Interest Group (IPIG) PNH registry. It is designed to characterize the long-term safety and tolerability of danicopan as add-on therapy to eculizumab or ravulizumab in adult participants with PNH.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants aged ≥ 18 years at danicopan treatment initiation (baseline) as add-on therapy to ravulizumab/eculizumab.
- •Initiated treatment with danicopan on or after registry enrollment
排除标准
- •Participants without known year of birth, sex, informed consent date, or treatment status of danicopan and ravulizumab and/or eculizumab treatment status.
研究组 & 干预措施
Danicopan
Participants with PNH treated with Danicopan as an add-on therapy to eculizumab or ravulizumab.
干预措施: Danicopan (Drug)
结局指标
主要结局
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Up to approximately 5 years
Number of Participants with Serious Infections Caused by Encapsulated Bacteria
时间窗: Up to approximately 5 years
次要结局
- Number of Participants Who Discontinue Study Treatment(Up to approximately 5 years)
- Frequency of Reasons for Discontinuation(Up to approximately 5 years)
研究者
研究点 (1)
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