NCT02614846Unknown1 期
A Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- The number of subjects with adverse events as a measure of safety and tolerability.
研究概览
简要总结
This study evaluates the safety and efficacy of 6 weeks dosing Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura Patients. All of the subjects in this study receive Hetrombopag.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Confirmed diagnosis of chronic ITP,a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia.
- •Patients had a platelet count of less than 30,000/µL both in the screening period and baseline.
- •Subjects who are refractory or have relapsed after at least one prior ITP therapy.
- •Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.
- •Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
- •A complete blood count (CBC), within the reference range, with the following exceptions.
- •Platelets <30×109/L is required for inclusion .
- •Hemoglobin: females and males 10.0 g/dl are eligible for inclusion.
- •Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion.
- •7.PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.
- •8.Female subjects have a negative result with HCG testing in the screening period and baseline.
排除标准
- •Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia.
- •Subjects diagnosed with tumor.
- •Have pre-existing cardiac disease within the last 3 months.No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block.
- •Female subjects who are nursing or pregnant at screening or pre-dose on baseline.
- •Treatment with thrombopoietin or an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
- •Treatment with Rituximab or Splenectomy within the lat 6 months.
- •Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days or five half-lives (whichever is longer).
- •Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks of the study start and until the end of the study.
- •Any laboratory or clinical evidence for HIV infection.Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening.
研究组 & 干预措施
Hetrombopag Olamine
Experimental
All the subjects receive 6 weeks Hetrombopag Olamine dosing, 5mg for the first 2 weeks, 2.5mg or 7.5mg for the last 4 weeks according to the PLT counting.
干预措施: Hetrombopag Olamine (Drug)
结局指标
主要结局
The number of subjects with adverse events as a measure of safety and tolerability.
时间窗: From Day 1 to Day 70.
次要结局
未报告次要终点
研究者
研究点 (1)
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