NCT04289207Unknown2 期
Phase II Trial of Romiplostim With Danazol in Patients With Eltrombopag-resistant Immune Thrombocytopenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 55
- 主要终点
- Response rate
研究概览
简要总结
In this study, we tried to demonstrate clinical benefit of additive danazol to romiplostim therapy in patients with eltrombopag-resistant immune thrombocytopenia
详细描述
The patients with eltrombopag-resistant immune thrombocytopenia are treated with romiplostim and danazol. The efficacy and toxicity of treatment will be evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged over 18 years
- •diagnosed with immune thrombocytopenia (bone marrow examination is not necessary)
- •failed to achieve platelet count over 50X10^9/L with eltrombopag
- •ECOG performance status 0,1,2
- •available to obtain informed consent
排除标准
- •Hepatitis B or C carriers
- •HIV positive patients
- •diagnosed with systemic lupus erythematosus or other autoimmune disorders
- •unable to intake orally or absorb through gastrointestinal tract
- •pregnant or breast-feeding
- •diagnosed with uncontrolled seizure or other neuropsychiatric disorders
- •diagnosed with clinically significant cardiovascular events within 6 months or dyspnea on exertion evaluated to New York Heart Association Functional Classification III or IV
- •diagnosed with clinically significant cerebrovascular disorders
- •previously diagnosed or treated with thromboembolism
- •current treating malignant diseases
- •currently accompanied by uncontrolled infection or active bleeding
- •with blood test results as follows; total bilirubin > 2xUNL(upper normal limit), AST/ALT > 1.5xUNL, creatinine > 1.5xUNL, glomerular filtration rate < 30ml/min/1.73m^2
- •registered to other clinical trials for treatment of immune thrombocytopenia
- •judged to be inappropriate for clinical trial by doctor in charge
研究组 & 干预措施
Romiplostim and danazol
Experimental
Treatment group (romiplostim and danazol)
干预措施: Romiplostim and danazol (Drug)
结局指标
主要结局
Response rate
时间窗: week 8
proportion of patients with platelet count over 50x10\^9/L
次要结局
- Effects on quality of life(week 24)
- Time to best response(week 24)
- Response duration(week 24)
研究者
Youngil Koh
Associate professor
Seoul National University Hospital
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