NCT06799546已完成3 期
A Phase III, Multicenter, Randomized, Open Label, Active-Controlled Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Naive to Complement Inhibitor Therapy
Haisco Pharmaceutical Group Co., Ltd.2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2025年2月13日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Proportion of participants achieving hemoglobin levels ≥ 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
The purpose of this study is to evaluate the efficacy and safety of HSK39297 tablets compared to eculizumab in Patients with PNH who Are Naive to Complement Inhibitor Therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years, Male and female patients;
- •Diagnosis of PNH based on flow cytometry with clone size > 10% by granulocytes;
- •Have not received complement inhibitor treatment;
- •Blood LDH values > 1.5 ×upper limit of the normal range (ULN) ;
- •Hemoglobin level < 10 g/dL at screening.
排除标准
- •Hereditary or acquired complement deficiency;
- •Active primary or secondary immunodeficiency;
- •History of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants;
- •History of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or Mycobacterium tuberculosis;
- •Patients with laboratory evidence of bone marrow failure (reticulocytes < 100x10^9/L, or platelets < 30x10^9/L or neutrophils < 0.5x10^9/L) ;
- •Active systemic infection within 2 weeks prior to study drug administration;
- •History of serious comorbidities that have been determined to be unsuitable for participation in the study.
- •Pregnant or Lactating women.
研究组 & 干预措施
HSK39297 tablets
Experimental
干预措施: HSK39297 tablets (Drug)
Eculizumab Injection
Active Comparator
干预措施: Eculizumab Injection (Drug)
结局指标
主要结局
Proportion of participants achieving hemoglobin levels ≥ 12 g/dL at least on three out of four measurements in the absence of red blood cell transfusions
时间窗: Between Week 18 and Week 24
次要结局
- Proportion of participants with increase in hemoglobin levels from baseline of ≥20 g/L at least on three out of four measurements in the absence of red blood cell transfusions(Between Week 18 and Week 24)
- Proportion of participants who did not receive blood transfusion.(Between Week 2 and Week 24)
- Proportion of participants with Major Adverse Vascular Events (MAVEs)(24 weeks)
- Change from baseline in hemoglobin(Baseline, week 18 to 24)
- Rate of breakthrough hemolysis (BTH)(24 weeks)
- Change From Baseline in Reticulocyte Count(Baseline, week 18 to 24)
- Percent change from baseline in LDH(Baseline, week 18 to 24)
- Change from baseline in FACIT-Fatigue score(Baseline, week 18 to 24)
研究者
研究点 (2)
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