NCT05842486已完成不适用
Hematological Response in Patients With Paroxysmal Nocturnal Hemoglobinuria Treated With Anti-C5 Antibody: an External Control Arm Study for Iptacopan Use in Anti-C5 naïve Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Increase from baseline in hemoglobin
研究概览
简要总结
The aim of this non-interventional secondary use of data study is to evaluate hematological response in patients with paroxysmal nocturnal hemoglobinuria and anemia in the 6-month period after initiation of anti-C5 antibody treatment using real-world data obtained from multiple datasets. The results will be used to contextualize results from the APPOINT-PNH (NCT04820530) trial with iptacopan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Incident users of anti-C5 antibody treatment (i.e., first use of anti-C5 antibody with no evidence of use prior to that)
- •Confirmed clinical diagnosis of PNH (including PNH clone size >10% in RBC percent/white blood cell (WBC) percent)
- •Adult patients ≥18 years of age
- •Baseline Hb <10 g/dL.
排除标准
- •Patients who met any of the following criteria were not eligible for inclusion.
- •Bone marrow transplantation within one year prior to initiating anti-C5 treatment
- •Hereditary complement deficiency
- •Reticulocyte count <60x10^9/L.
结局指标
主要结局
Increase from baseline in hemoglobin
时间窗: between Day 100 and Day 200
Increase from baseline in hemoglobin of ≥ 2 g/dL in the absence of transfusions occurring after Day 14 post index date
次要结局
- Hemoglobin Response(between Day 100 and Day 200)
- Transfusion avoidance(Occurrence between Day 15 and Day 200)
研究者
研究点 (1)
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