NCT06745622招募中2 期
A Multicenter, Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy 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: 2025年1月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
This is a multicenter, open-label study to evaluate the long-term safety, tolerability and efficacy of HSK39297. Adult patients with PNH who had previously received and completed HSK39297 study treatment will be included. Eligible subjects can maintain HSK39297 treatment until the end of the 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
- •Patients With PNH who have previously received and completed HSK39297 treatment , and According to the researchers' judgment, the benefits of treatment outweigh the risks and may benefit from continued treatment with HSK39297;
- •Understand the study procedures and methods, voluntarily participate in this trial.
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;
- •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
Incidence and severity of adverse events
时间窗: through study completion，about 2 years
次要结局
- Proportion of participants achieving hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions(through study completion，about 2 years)
- Change From Baseline in Hemoglobin in the absence of red blood cell transfusions(through study completion，about 2 years)
- Proportion of participants who remain free from transfusions(through study completion，about 2 years)
- Rate of breakthrough hemolysis (BTH)(through study completion，about 2 years)
- Proportion of participants with Major Adverse Vascular Events (MAVEs)(through study completion，about 2 years)
研究者
研究点 (1)
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