NCT05027230已完成1 期
A Phase Ib/II,Multi-center, Open, Multiple-dose Design to Evaluate the Safety,Tolerability and Efficacy of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
Staidson (Beijing) Biopharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2021年10月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Proportion of successfully treated bleeding episodes
研究概览
简要总结
This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤age≤65 years of age,male.
- •Hemophilia A or B patients with inhibitors.
- •Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase
- •Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
- •Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- •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 A or B.
- •Treat with prophylactic treatment of coagulation factor.
- •Treat with anticoagulant within 7d of the time of study drug administration.
- •Have a history of arterial and/or venous thromboembolic events.
- •Have platelet <100,000/mL,hemoglobin<90g/L.
- •Severe liver or kidney disease.
- •Bleeding in the central nervous system or throat before screening.
- •Accept major operation or blood transfusion within 1 month of the time of screening.
- •HIV positive with current CD4+ count of less than 200/μl.
- •Have a known allergy to Blood product.
- •Participate in other clinical research within 1 month of the time of study drug administration.
- •Treat with coagulant within 7d of the time of study drug administration.
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
Proportion of successfully treated bleeding episodes
时间窗: 24 hours after administration of study drug
Incidence of adverse events
时间窗: From day 0 to up to day 8
次要结局
- Proportion of bleeding episodes with clinical relief of signs and symptoms(4 hours、8 hours、24 hours after first administration of study drug)
研究者
研究点 (1)
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