jRCT2080224916已完成3 期
A Phase 3 Study in Patients with Chronic Idiopathic Thrombocytopenic Purpura in R788
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Achievement rate of stable platelet response
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Placebo-controlled, Multicenter, Randomized, Double-blind, Parallelgroup Study And A Multicenter, Open-label Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients diagnosed with ITP at least 6 months before acquisition of consent
- •Patients with a platelet count average of < 30000/uL during screening period and with each platelet count < 35000/uL
- •Patients who have used and failed at least 1 of the typical ITP medications before informed consent
排除标准
- •Patients with thrombocytopenia associated with other diseases
- •Patients with autoimmune hemolytic anemia
- •Patients with poor blood pressure control
- •Patients with or with a history of a history of coagulopathy
结局指标
主要结局
Achievement rate of stable platelet response
时间窗: Weeks 14 to 24
Subjects who achieve a platelet count of >= 50000/uL on at least 4 of the 6 visits from Weeks 14 to 24 are considered as a responder and the percentage of responders will be evaluated
次要结局
- Achievement rate of overall response(Weeks 2 to 12)
- Duration of maintained platelet count since first achievement of a platelet count >= 50000/uL after administration of the study drug
- Achievement rate of a platelet count of >= 50000/uL at the specified evaluation time point
- Achievement rate of a platelet count of >= 30000/uL at the specified evaluation time points and platelet count increase at least 20000/uL above baseline
研究者
研究点 (1)
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