NCT02553317已完成3 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
Ablynx, a Sanofi company103 个研究点 分布在 10 个国家目标入组 145 人开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 103
- 主要终点
- Time to Platelet Count Response
研究概览
简要总结
The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
- •Clinical diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) (initial or recurrent), which included thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
- •Required initiation of daily PE treatment and had received 1 PE treatment prior to randomization
- •Others as defined in the protocol
排除标准
- •Platelet count ≥100×10E9/L.
- •Serum creatinine level >200 µmol/L in case platelet count is > 30×10E9/L
- •Known other causes of thrombocytopenia
- •Congenital TTP (known at the time of study entry).
- •Pregnancy or breast-feeding.
- •Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown
- •Others as defined in the protocol
结局指标
主要结局
Time to Platelet Count Response
时间窗: Only data from the DB daily PE period (median = 5 days) up to the cut-off were used. The cut-off point was defined by whichever occured first: 1) 45 days of daily PE after start of study drug, 2) stop of daily PE, 3) stop of study drug (median = 34 days)
Platelet count response was defined as initial platelet count ≥ 150,000/μL with subsequent stop of daily PE within 5 days. It refers to the first time both conditions, platelet count ≥ 150,000/μL and the stop of daily PE within 5 days, were met.
次要结局
- Number and Percentage of Subjects With Refractory Disease(The study drug treatment period, a median (min, max) of 36 (2, 82) days.)
- Number and Percentage of Subjects With TTP-Related Death, Recurrence of TTP, or a Major Thromboembolic Event During the Study Drug Treatment Period(The study drug treatment period, a median (min, max) of 36 (2, 82) days. For both treatment groups, only events that occurred prior to a switch to open-label caplacizumab were evaluated for this analysis.)
- Number and Percentage of Subjects With a Recurrence of TTP in the Overall Study Period(The overall study period (covers both the overall treatment period and the follow-up period), a median (min, max) of 65 (2, 110) days.)
- Time to Normalization of Organ Damage Marker Levels(Overall study period, a median (min, max) of 65 (2, 110) days. For both treatment groups, normalizations occurring during the open-label period were not evaluated in this analysis.)
研究者
研究点 (103)
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