The Combination of Iguratimod and Danazol Versus Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: A Randomized, Controlled, Multicenter, Open-label Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Sustained response
研究概览
简要总结
Randomized, open-label, multicenter study to compare the efficacy and safety of combination of iguratimod and danazol versus danazol for the treatment of adults with steroid-resistant/ relapse immune thrombocytopenia (ITP).
详细描述
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with steroid-resistant/ relapse ITP in China. Patients were randomized to Iguratimod plus danazol and danazol monotherapy group. 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
- Randomized
- 干预模型
- Parallel
- 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 30×109/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 and Danazol
Iguratimod is given at a dose of 25 mg bid. Danazol is given at 200mg bid for 12 weeks.
干预措施: Iguratimod (Drug)
Iguratimod and Danazol
Iguratimod is given at a dose of 25 mg bid. Danazol is given at 200mg bid for 12 weeks.
干预措施: Danazol (Drug)
Danazol
Danazol is given at 200mg bid for 12 weeks.
干预措施: Danazol (Drug)
结局指标
主要结局
Sustained 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. Interim analysis was scheduled at 50% through recruitment.
次要结局
- Complete remission(6 months)
- Incidence of treatment-emergent adverse events(6 months)
- Time to response(6 months)
- Duration of response(6 months)
- Partial remission(6 months)
研究者
Xiao Hui Zhang
Vice president of Peking University Institute of Hematology
Peking University People's Hospital