A Prospective, Open, Multicenter Clinical Trial of Eltrombopag Combined With Diacerein in the Management of Eltrombopag-inefficient or Relapsed ITP
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of platelet response
研究概览
简要总结
Eltrombopag is an oral thrombopoietin receptor agonist that has been licensed for use as second line therapy in ITP patients. Diacerein is a slow-acting medicine of the class anthraquinone used to treat joint diseases such as osteoarthritis. The project was undertaking by Qilu Hospital of Shandong University and other 5 well-known hospitals in China. In order to report the efficacy and safety of eltrombopag combined with diacerein in the management of ITP.
详细描述
The investigators are undertaking a prospective, open, multicentre trial of 30 ITP adult patients with eltrombopag-inefficient or relapsed from 6 medical centers in China. The initial dose of eltrombopag administration is 25 mg orally once daily, which could be transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The treatment was discontinued after 6 weeks without blood index reaction.
Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of eltrombopag combined with diacerein for the treatment of adults patients with eltrombopag-inefficient or relapsed.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ITP patients with eltrombopag-inefficient or relapsed need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia
排除标准
- •pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome
研究组 & 干预措施
drugs
Eltrombopag and Diacerein
干预措施: Eltrombopag and Diacerein (Drug)
结局指标
主要结局
Evaluation of platelet response
时间窗: the sixth weeks
R. A response (R) was defined as platelet count ≥ 30×10\^9/L without bleeding
次要结局
未报告次要终点
研究者
Ming Hou
Professor and Director
Shandong University