CTRI/2021/02/031507尚未招募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 withHemophilia A or Hemophilia B, with Inhibitors: The Crimson 1 Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 8
- 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
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.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 4.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
次要结局
- 1)To cessation of bleeding(2)To To assess the ability of MarzAA to achieve and maintain hemostasis)
研究者
研究点 (8)
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