EUCTR2015-001098-42-Outside-EU/EEA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
- 132
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 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: 10
- •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
- •4. Congenital TTP (known at the time of study entry)
- •5. Pregnancy or breast-feeding.
- •6. Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown.
研究者
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