NCT06922045进行中（未招募）3 期
A Phase III Clinical Study on the Efficacy and Safety of STSP-0601 for Injection in Patients With Hemophilia Associated With Inhibitors, With a Multicenter, Open Evaluation Approach
Jiangsu BioJeTay Biotechnology Co., Ltd.44 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 44
- 主要终点
- 12 hours effective hemostasis rate
研究概览
简要总结
This study will assess the 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
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 ≤age≤70 years of age.
- •Hemophilia A or B patients.
- •Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- •Establish proper venous access.
- •There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
- •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.
- •Patients plan to receive Emicizumab during the trial.
- •Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.
- •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 the first administration.
- •Accepted major operation or blood transfusion within 4 weeks before the first administration.
- •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 before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received.
- •Patients not suitable for the trail according to the judgment of the investigators.
研究组 & 干预措施
Continuous administration of STSP-0601
Experimental
干预措施: STSP-0601 for Injection (Drug)
结局指标
主要结局
12 hours effective hemostasis rate
时间窗: 12 hours after the first administration
次要结局
- Effective hemostasis rate at the first 12 hours bleeding visit(12 hours after the first administration)
- 12 hours excellent + good rate(12 hours after the first administration)
- The number of medication required for effective hemostasis within 12 hours(12 hours after the first administration)
- The amount of medication (U/kg) required for effective hemostasis within 12 hours(12 hours after the first administration)
- 8-hours effective hemostasis rate(8 hours after the first administration)
- 8-hours excellent + good rate(8 hours after the first administration)
- Complete + significant relief rate(4 hours, 8 hours, 12 hours, 24 hours after the first administration)
- The time to achieve complete/significant remission after the first administration(From the time after the first administration until within 72 hours after the last administration)
- Rescue treatment rate(Within 72 hours after the last administration)
- The time from the onset of bleeding to complete/significant relief(Within 72 hours after the last administration)
- The effective hemostasis rate of the target joint(From 12 hours after the first administration to 72 hours after the last administration)
研究者
研究点 (44)
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