A Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune Thrombocytopenia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of rhTPO .
详细描述
The eligible subjects with ITP firstly will receive a pre-treatment of rhTPO 300 IU/Kg once daily up to 14 days. The subjects with two consecutive platelet counts above 50×10^9/L in the pre-treatment period will begin to receive maintenance treatment of rhTPO 300 IU/Kg for 12 weeks. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30 ×10^9/L～100 ×10^9/L. Subsequently, subjects will stop treatment of rhTPO and be followed up for 4 weeks after maintenance treatment.
Platelet count, bleeding and other symptoms will be evaluated before and after treatment.
Platelet transfusion will be administered to subjects with active bleeding symptoms.
Toxicity will be monitored continuously during the entire study. Safety will be assessed by adverse events and laboratory tests.
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
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria for immune thrombocytopenia (idiopathic thrombocytopenic purpura).
- •Subject with resistance to or relapse after glucocorticoid in the treatment of ITP, not accepts splenectomy, or subject with ineffective or relapse after surgical splenectomy.
- •Two consecutive platelet counts (not in the same day) < 30×10^9/L.
- •Subject is willing and able to provide written informed consent.
排除标准
- •Pregnancy or breast feeding.
- •Having a medical history of thrombosis.
- •Significant abnormal cardio-pulmonary function.
- •Abnormal liver and kidney function:
- •a serum creatinine concentration≥ 176.8µmol/l (1.5mg/dl);
- •a serum aminotransferase concentration: more than 2.0 times the upper limit of the normal range.
- •a serum bilirubin concentration: more than 2.0 times the upper limit of the normal range.
- •Synchronous tumor.
- •Cannot adopt adequate contraceptive precautions during the course of the study.
- •Any other treatment drugs for ITP are being taken (except the duration of reducing glucocorticoid dosage as ineffective treatment ).
- •Any other situation that is not suitable for participating in the trial according to the judgment of the investigator .
研究组 & 干预措施
rhTPO
Active investigational product
干预措施: rhTPO (Drug)
结局指标
主要结局
The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L)
时间窗: up to 16 weeks per subject
次要结局
- The effective rate of maintenance treatments adopting different frequency of administration(up to 16 weeks per subject)
- Number of subjects with Adverse Events as a Measure of Safety(up to 18 weeks per subject)
研究者
Yongqiang Zhao
The Director of Hematology Department of Peking Union Medical College Hospital
Peking Union Medical College