NCT05619926已完成2 期
A Multi-center, Open-label, Multiple-dose Design, Phase 2 Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients With Hemophilia Without Inhibitor
Staidson (Beijing) Biopharmaceuticals Co., Ltd12 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年1月9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
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 12
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 ≤age≤70 years of age,male;
- •Hemophilia A or B patients;
- •A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage);
- •Factor VIII or IX level <2%, inhibitor titer < 0.6 BU;
- •There were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (Only the second stage is applicable);
- •Establish proper venous access;
- •Agree to use adequate contraception to avoid pregnancy;
- •Provide signed informed consent.
排除标准
- •Have any coagulation disorder other than hemophilia;
- •Plan to receive prophylactic treatment of coagulation factor during the trail;
- •4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab during the trial;
- •Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial;
- •Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment;
- •Have a history of arterial and/or venous thrombotic events;
- •Platelet <100×109/L;
- •Hemoglobin<90g/L;
- •Severe liver or kidney disease;
- •Severe bleeding event occurred within 4 weeks before enrollment;
- •Accepted major operation or blood transfusion within 4 weeks before enrollment;
- •HIV positive;
- •Have a known allergy to STSP-0601;
- •Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails);
- •Patients not suitable for the trail according to the judgment of the investigators.
研究组 & 干预措施
Consecutive doses of low-dose of STSP-0601
Experimental
干预措施: STSP-0601 for Injection (Drug)
Consecutive doses of high-dose of STSP-0601
Experimental
干预措施: STSP-0601 for Injection (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: From day 0 to up to day 4
Proportion of successfully treated bleeding episodes
时间窗: 8 hours after first administration of study drug
次要结局
- Proportion of successfully treated bleeding episodes(12 hours，24 hours after first administration of study drug)
- Proportion of bleeding episodes received salvage treatment(Within 3 months after enrollment)
研究者
研究点 (12)
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