Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: a Phase 2, Open-label, Single-arm Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Durable response
研究概览
简要总结
A phase 2, open-label, single-arm study to evaluate the efficacy and safety of iguratimod for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP)
详细描述
The investigators are undertaking an open-label, single-arm study of 100 adults with steroid-resistant/ relapse ITP in China. Patients were received Iguratimod treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
- •Platelet count of less than 30×10^9/L at enrollment;
- •Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
- •18 years older;
排除标准
- •Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
- •Congestive heart failure
- •Severe arrhythmia
- •Nursing or pregnant women
- •Aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
- •Creatinine or serum bilirubin levels each 1•5 times or more than the normal range
- •Active or previous malignancy
- •Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
研究组 & 干预措施
Iguratimod treatment
Iguratimod is given at a dose of 25 mg bid for 12 weeks.
干预措施: Iguratimod (Drug)
结局指标
主要结局
Durable response
时间窗: 6 months
The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.
次要结局
- Remission(12 months)
- Bleeding(12 months)
- Initial response(1 month)
- Time to response(12 months)
- Adverse events(12 months)
研究者
Xiao Hui Zhang
Vice president of Peking University Institute of Hematology
Peking University People's Hospital