NCT03232177已完成4 期
A Multicenter, Open-label, Clinical Study for Efficacy and Safety Evaluation of Anagrelide in Patients With Treatment-naïve, High-risk Essential Thrombocythemia as a Primary Treatment
Yuhan Corporation20 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年6月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 20
- 主要终点
- response rate for less than 60 X 10^4/ul in platelet count
研究概览
简要总结
This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks and duration of administration for 1 year in patients with high-risk essential thrombocythemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with essential thrombocythemia according to WHO 2008
- •Any of the following as high-risk patient
- •Over 60 years old
- •>100 X 10^4/ul of platelet count
- •increased more than 300K of platelet count in 3 months
- •Hypertension, diabetes, past history of thromboembolic bleeding
排除标准
- •Patients with an adverse drug reaction or intolerability to anagrelide
- •Any of the following cardiac abnormalities;
- •Complete left bundle branch block on ECG
- •Patients using a pacemaker
- •Patients with a family history of congenital QT prolongation syndrome or known QT prolongation syndrome
- •Currently, there is no clinically uncontrolled ventricular or atrial tachycardia
- •Clinically significant bradycardia (<less than 50 per minute)
- •History of clinically proven myocardial infarction and unstable angina within 3 months
- •Pregnant women, nursing mothers
研究组 & 干预措施
Anagre Cap.
Experimental
twice a day
干预措施: Anagre Cap. (Drug)
结局指标
主要结局
response rate for less than 60 X 10^4/ul in platelet count
时间窗: at week 8
次要结局
- response rate for less than 40 X 10^4/ul in platelet count(up to 52 weeks)
- response rate for less than 60 X 10^4/ul in platelet count(at week 52)
- changes from baseline in 50% reduction rate in platelet count(up to 52 weeks)
- cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events)(at 52 week)
- incidence of adverse events(up to 52 weeks)
研究者
研究点 (20)
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