A Study of Orelabrutinib in Patients With Primary Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall response (OR)
研究概览
简要总结
This project was undertaken to evaluate the efficacy and safety of BTK inhibitor Orelabrutinib for the secondary treatment of adults with primary immune thrombocytopenia (ITP).
详细描述
The investigators are undertaking a prospective trial of 10 adults with ITP in China. Orelabrutinib is administered as 50 mg po. qd for 6 weeks. 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
- •Confirmed primary refractory ITP
- •Platelet counts <30×10^9/L or with bleeding symptoms
- •Willing and able to sign written informed consent
排除标准
- •Secondary thrombocytopenia
- •Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit
- •HIV infection or hepatitis B virus or hepatitis C virus infections
- •Malignancy
- •Severe medical condition (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- •Nursing or pregnant patients
- •Patients who are deemed unsuitable for the study by the investigator
研究组 & 干预措施
Orelabrutinib
Orelabrutinib 50mg po qd 6 weeks
干预措施: Orelabrutinib (Drug)
结局指标
主要结局
Overall response (OR)
时间窗: 6 weeks
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-week follow-up.
次要结局
- Side effects(6 weeks)
- Complete response (CR)(6 weeks)
- Time to response(6 weeks)
- Bleeding events(6 weeks)
研究者
Xiao Hui Zhang
Clinical Professor
Peking University People's Hospital