NCT06568302终止3 期
A Global Open-label Extension Study to Observe the Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- ApcinteX Ltd
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Treated bleeds, expressed as annualized bleeding rate (ABR)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants greater than or equal to (>=) 12 and less than or equal to (<=) 65 years of age at the time of informed consent
- •Completed participation in a sponsored SerpinPC hemophilia clinical trial and, in the opinion of the investigator, was compliant with the study including compliance with diary entries.
- •Capable of providing written informed consent (adolescent assent and parent/guardian consent when appropriate) for participation
排除标准
- •Previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or embolic stroke
- •Participation in another interventional clinical trial, except for SerpinPC trials
- •Any other significant conditions or comorbidities that, in the opinion of the investigator, would make the subject unsuitable for enrolment or could interfere with participation in or completion of the study
- •Treatment with anticoagulant or antiplatelet drugs
研究组 & 干预措施
SerpinPC
Experimental
Participants will receive SerpinPC 1.2 milligrams/kilograms (mg/kg) subcutaneous injection every 2 weeks (Q2W) once they have completed treatment in a SerpinPC parent study.
干预措施: SerpinPC (Drug)
结局指标
主要结局
Treated bleeds, expressed as annualized bleeding rate (ABR)
时间窗: Month 0 to Month 25 or Early termination
次要结局
- Treated spontaneous joint bleeds (expressed as ABR)(Month 0 to Month 25 or Early termination)
- All bleeds requiring treatment (expressed as ABR, ie, all treated bleeds and all bleeds that would ordinarily be treated with factor concentrate/bypass agent if therapy were available)(Month 0 to Month 25 or Early termination)
- Treated spontaneous bleeds (expressed as ABR)(Month 0 to Month 25 or Early termination)
- Total coagulation factor and/or bypass product consumption(Month 0 to Month 25 or Early termination)
研究者
研究点 (2)
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