NCT06238544进行中（未招募）2 期
An Open Label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events.
研究概览
简要总结
This is a multicenter, single-arm, open-label study. Patients with Paroxysmal Nocturnal Hemoglobinuria who had previously received and completed the HRS-5965 study well included. All eligible subjects received HRS-5965 tablets or capsules until the end of treatment in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •1. Patients who have previously received and completed HRS-5965 study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of HRS-5965 and patients in the control group of who received eculizumab treatment.
排除标准
- •Known or suspected hereditary or acquired complement deficiency;
- •History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
研究组 & 干预措施
HRS-5965 Group
Experimental
干预措施: HRS-5965 tablets (Drug)
HRS-5965 Group
Experimental
干预措施: HRS-5965 Capsules (Drug)
结局指标
主要结局
Incidence and severity of adverse events.
时间窗: Every six months,for about 3 years
次要结局
- Proportion of participants who remain free from transfusions was assessed every half a year during treatment..(Every six months,for about 3 years)
- Proportion of participants with Major Adverse Vascular Events MAVEs.(Every six months,for about 3 years)
- Plasma concentration of HRS-5965.(Start of Treatment to end of study，for about 3 years)
- Proportion of participants achieving sustained hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions was assessed every half a year during treatment..(Every six months ,for about 3 years)
- Rate of breakthrough hemolysis was assessed every half a year during treatment(Every six months,for about 3 years)
研究者
研究点 (2)
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