NCT07052838已完成3 期
A Multicenter, Single-Arm, Open-Label Phase III Clinical Study Evaluating the Efficacy and Safety of HSK39297 Tablets in Paroxysmal Nocturnal Hemoglobinuria Patients With Anemia Despite Stable Anti-C5 Antibody Therapy
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
- 36
- 试验地点
- 2
- 主要终点
- Proportion of participants achieving hemoglobin levels ≥ 120 g/L 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 of HSK39297 tablets in paroxysmal nocturnal hemoglobinuria (PNH) patients with anemia after stable treatment of anti-C5 antibody.
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 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 showing >10% granulocyte clone size during the screening period.
- •Stable use of Anti-C5 antibody at least 6 months prior to enrollment.
- •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 < 100x109/L, or platelets < 30x109/L or neutrophils < 0.5x109/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
Experimental
干预措施: HSK39297 tablets (Drug)
结局指标
主要结局
Proportion of participants achieving hemoglobin levels ≥ 120 g/L at least on three out of four measurements in the absence of red blood cell transfusions
时间窗: 18 to 24 weeks
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(18 to 24 weeks)
- Percentage of patients who did not receive a blood transfusion.(18 to 24 weeks)
- Change from baseline in hemoglobin(Baseline, week 18 to 24)
- Change From Baseline in Reticulocyte Count(Baseline, week 18 to 24)
- Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue score(Baseline, week 18 to 24)
- Percent change from baseline in lactate dehydrogenase (LDH)(Baseline, week 18 to 24)
- Rate of breakthrough hemolysis (BTH)(24 weeks)
- Proportion of participants with Major Adverse Vascular Events (MAVEs)(24 weeks)
研究者
研究点 (2)
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