NCT06051357已完成2 期
An Multicenter, Randomized, Open-label Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Changes in hemoglobin.
研究概览
简要总结
This is a multicenter, randomized, open-label phase II clinical trial. A total of 24 patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HRS-5965 for 12 weeks.
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;
- •Hemoglobin level < 10 g/dL.
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
Treatment group A
Experimental
干预措施: HRS-5965 tablets (Drug)
Treatment group B
Experimental
干预措施: HRS-5965 tablets (Drug)
结局指标
主要结局
Changes in hemoglobin.
时间窗: 12 weeks
次要结局
- Plasma concentration of HRS-5965.(12 weeks)
- Incidence of thromboembolic events.(16 weeks)
- Changes in LDH.(12 weeks)
- Changes in haptoglobin.(12 weeks)
- Changes in C3 complement fragment deposition.(12 week)
- Incidence and severity of adverse events(16 weeks)
- Changes in reticulocyte counts.(12weeks)
- Number of RBC units of transfused.(12weeks)
- Changes in bilirubin.(12 weeks)
- Percentage of patients who did not receive a blood transfusion.(12 weeks)
研究者
研究点 (2)
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