NCT04489537终止3 期
Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (Activated) For On Demand Treatment and Control of Bleeding Episodes in Subjects With Hemophilia A or Hemophilia B, With Inhibitors: The Crimson 1 Study
Catalyst Biosciences58 个研究点 分布在 16 个国家目标入组 18 人开始时间: 2021年5月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 58
- 主要终点
- Bleeding episode treatment success
研究概览
简要总结
The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of congenital hemophilia A or B with inhibitors
- •Male or Female, age 12 or older
- •History of frequent bleeding episodes
- •Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities
排除标准
- •Previous participation in a clinical trial evaluating a modified rFVIIa agent
- •Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect
- •Known hypersensitivity to trial or related product
- •Known positive antibody to FVII or FVIIa detected by central lab at screening
- •Have a coagulation disorder other than hemophilia A or B
- •Be immunosuppressed
- •Significant contraindication to participate
结局指标
主要结局
Bleeding episode treatment success
时间窗: 24 hours after the first administration of study drug
Proportion of bleeding events treated with MarzAA achieving hemostatic efficacy based on a four-point scale according to the Investigator's assessment compared with standard of care.
次要结局
未报告次要终点
研究者
研究点 (58)
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