A Phase III Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Achievement Rate of Stable Platelet Response
研究概览
简要总结
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of R788 compared with placebo, and to investigate the safety and efficacy of long term dosing of R788 in patients with chronic idiopathic thrombocytopenic purpura.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients
- •Patients diagnosed with idiopathic thrombocytopenic purpura at least 6 months before acquisition of consent
- •Patients with a platelet count averages <30000/μL during screening period. Each platelet count should not exceed 35000/μL.
- •Patients who have used and failed or who were intolerant at least 1 typical regimen for the treatment of ITP before informed consent (with or without splenectomy)
排除标准
- •Patients with thrombocytopenia associated with other disease
- •Patients with autoimmune hemolytic anemia
- •Patients with poorly controlled hypertension
- •Patients with a history or active coagulopathy
研究组 & 干预措施
R788
Patients are administered R788 for 24 weeks (double-blind period), followed by R788 for up to 52 weeks (open-label period). Patients who have completed open-label period and meet the criteria are eligible to continue R788 treatment over a 3 year period (extension - period).
干预措施: R788 (Drug)
Placebo
Patients are administered Placebo for 24 weeks (double-blind period), followed by R788 for up to 28 weeks (open-label period). Patients who have completed open-label period and meet the criteria are eligible to continue R788 treatment over a 3 year period (extension - period).
干预措施: R788 (Drug)
Placebo
Patients are administered Placebo for 24 weeks (double-blind period), followed by R788 for up to 28 weeks (open-label period). Patients who have completed open-label period and meet the criteria are eligible to continue R788 treatment over a 3 year period (extension - period).
干预措施: Placebo (Drug)
结局指标
主要结局
Achievement Rate of Stable Platelet Response
时间窗: 24 weeks (Period I)
The percentage of subjects who achieved stable platelet response (defined as a platelet count of ≥50000/μL at 4 or more of the 6 visits from Weeks 14 to 24)
次要结局
未报告次要终点