NCT06561841已完成2 期
A Multicenter, Randomized, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH）
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2024年7月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Proportion of participants with increase in hemoglobin levels from baseline of ≥20 g/L in the absence of red blood cell transfusions
研究概览
简要总结
This is a multicenter, randomized, open-label phase 2 study. Adult Patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HSK39297 for 24 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
- •Male and female participants ≥ 18 years of age;
- •Diagnosis of PNH based on flow cytometry with clone size > 10% by granulocytes;
- •Have not received complement inhibitor treatment;
- •Blood lactate dehydrogenase(LDH) values > 1.5 ×upper limit of the normal range (ULN) ;
- •Hemoglobin level < 100 g/L during the screening period.
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
Treatment group C
Experimental
干预措施: HSK39297 (Drug)
Treatment group A
Experimental
干预措施: HSK39297 (Drug)
Treatment group B
Experimental
干预措施: HSK39297 (Drug)
结局指标
主要结局
Proportion of participants with increase in hemoglobin levels from baseline of ≥20 g/L in the absence of red blood cell transfusions
时间窗: Baseline, 24 weeks
次要结局
- Change from baseline in hemoglobin(Baseline, 24 weeks)
- Change from baseline in reticulocyte count(Baseline, 24 weeks)
- Change from baseline in LDH(Baseline, 24 weeks)
- Change from baseline in free hemoglobin(Baseline, 24 weeks)
- Change in the average number of RBC transfused per week(From week 4 to week 24)
- Change from baseline in FACIT-Fatigue score(Baseline, 24 weeks)
- Proportion of participants with at least 60% reduction in LDH compared to baseline or LDH below the upper limit of normal(Baseline, 24 weeks)
- Change from baseline in C3 fragment deposition on PNH RBC(Baseline, 24 weeks)
- Proportion of participants without requiring red blood cells (RBC) transfusions(From week 4 to week 24)
- Change from baseline in Indirect bilirubin(Baseline, 24 weeks)
- Change from baseline in PNH RBC clone size(Baseline, 24 weeks)
- Incidence and severity of adverse events(28 weeks)
研究者
研究点 (1)
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