NCT06289166已完成2 期
A Multi-center, Open-label, Phase Ⅱb Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients with Hemophilia with Inhibitor
Staidson (Beijing) Biopharmaceuticals Co., Ltd20 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年3月18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
- 25
- 试验地点
- 20
- 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 inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •18 ≤age≤70 years of age,male.
- •Hemophilia A or B patients. (No less than 3 patients with hemophilia B)
- •Peak historical inhibitor titer ≥ 5 BU and apositive inhibitor test when enrolled.
- •Establish proper venous access.
- •There were at least 3 bleeding events that requiring treatment occurred in the past 6 months before screening (Only applicable to the on-demand treatment stage).
- •Agree to use adequate contraception to avoid pregnancy. Agree not to donate sperm or eggs.
- •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.
- •Patients plan to receive Emicizumab 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.
- •Have a known allergy to STSP-
- •Pregnant, lactating, or blood pregnancy test positive female subjects
- •Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
- •Within 1 day prior to enrollment, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days prior to enrollment, prothrombin complex, FVIII, and FIX were used. Within 4 weeks prior to enrollment, treatment with amisulumab was received.
- •Patients not suitable for the trail according to the judgment of the investigators.
研究组 & 干预措施
Consecutive doses 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: 12 hours after first administration of study drug
次要结局
- Proportion of successfully treated first bleeding episodes(12 hours after first administration of study drug)
- Proportion of bleeding episodes received salvage treatment(24 hours after first administration of study drug)
- Proportion of successfully treated bleeding episodes(8 hours after first administration of study drug)
- Proportion of successfully treated Target joint bleeding episodes(12 hours after first administration of study drug)
- Excellent + good rate of treated bleeding episodes(8 hours after first administration of study drug)
- Number of doses required for effective hemostasis(12 hours after first administration of study drug)
- Time to complete/significant remission from first dose(72 hours after last administration of study drug)
- Time to complete/significant remission from haematogenesis(72 hours after last administration of study drug)
研究者
研究点 (20)
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