EUCTR2015-001098-42-IT进行中（未招募）1 期
A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura - HERCULES
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ABLYNX NV
- 入组人数
- 145
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Adult male or female = 18 years of age at the time of signing the informed consent form (ICF) or,
- •Male or female child (aged = 2 to < 12 years) or adolescent (aged = 12 to <18 years) at the time of obtaining informed consent/assent (as applicable).
- •2.Clinical diagnosis of acquired TTP (initial or recurrent), which includes thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g. schistocytes)
- •3.Requires initiation of daily PE treatment and has received PE treatment prior to randomization for adult subjects, and prior to start of first dose of study drug for pediatric subjects.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1.Platelet count =100×10E9/L
- •2.Serum creatinine level >200 µmol/L in case platelet count is >30×109/L
- •3.Known other causes of thrombocytopenia
研究者
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