NCT06593938已完成3 期
A Multicenter, Randomized, Open-label, Active-comparator Controlled Phase III Study to Evaluate the Efficacy and Safety of HRS-5965 Capsule in Patients With Paroxysmal Nocturnal Hemoglobinuria
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Proportion of subjects with the hemoglobin levels are ≥ 12 g/dL at least on three out of four measurements in the absence of red blood cell transfusions
研究概览
简要总结
A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of PNH confirmed by flow cytometry with clone size > 10%.
- •Have not received complement inhibitor therapy;
- •LDH > 1.5*ULN at screening.
- •Hemoglobin level < 10 g/dL at screening.
排除标准
- •Known or suspected hereditary or acquired complement deficiency;
- •Patients with laboratory evidence of bone marrow failure (reticulocytes <100x109/L; platelets <30x109/L; neutrophils <0.5x109/L);
- •Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of HRS-5965;
- •History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
- •Positive of HIV, HBsAg or HCVAb.
研究组 & 干预措施
HRS-5965 capsule
Experimental
干预措施: HRS-5965 capsule (Drug)
Eculizumab Injection
Experimental
干预措施: Eculizumab Injection (Drug)
结局指标
主要结局
Proportion of subjects with the hemoglobin levels are ≥ 12 g/dL at least on three out of four measurements in the absence of red blood cell transfusions
时间窗: 24 weeks
次要结局
- Proportion of subjects with the change from baseline in hemoglobin is ≥ 2 g/dL at least on three out of four measurements in the absence of red blood cell transfusions(24 weeks)
- Proportion of subjects who absence of administration of red blood cell transfusions(24 weeks)
- Mean change from baseline in hemoglobin(24 weeks)
- Mean percent change from baseline in LDH levels(24 weeks)
- Mean change from baseline in reticulocyte counts(24 weeks)
- Mean change from baseline in FACIT-Fatigue scores(24 weeks)
研究者
研究点 (2)
Loading locations...
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