NCT02868060已完成1 期
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
Kyowa Kirin China Pharmaceutical Co., Ltd.5 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- The incidence of all adverse events including evaluation of antidrug antibody status
研究概览
简要总结
The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.
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
- •Diagnosed with immune thrombocytopenia (ITP) for at least 6 months prior to signing the informed consent form (ICF).
- •Subject is ≥ 18 years old and ≤ 70 years old while signing the ICF.
- •Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP. Excluded having previously received recombinant human thrombopoietin (rHuTPO) or any other thrombopoietin receptor agonist.
- •The mean of 3 scheduled platelet counts taken during the screening period must be: < 30 ×10^9/L, with none >35×10^9/L.
排除标准
- •Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP.
- •Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF.
- •Had received Eltrombopag, recombinant human thrombopoietin (rHuTPO) or other myeloproliferative leukemia (MPL) stimulation product.
- •Received hematopoietic growth factors (e.g., granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11) for any reason within 4 weeks prior to signing the ICF.
- •Received any anti-malignancy agents (e.g., cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, interferon-alfa) for any reason within 8 weeks prior to signing the ICF.
- •Received any monoclonal antibody drugs (e.g., rituximab) for any reason within 14 weeks prior to signing the ICF.
- •Less than 4 weeks since end of any clinical trials about therapeutic drug or device for any indication prior to signing the ICF.
- •Pregnant or breast feeding.
- •In the opinions of the principal investigator or investigators, the patients are not suitable for participation in this trial.
研究组 & 干预措施
1 mcg/kg AMG531
Experimental
The administration of Romiplostim will be performed on Day 1 and 8
干预措施: Romiplostim (Drug)
3 mcg/kg AMG531
Experimental
The administration of Romiplostim will be performed on Day 1 and 8
干预措施: Romiplostim (Drug)
结局指标
主要结局
The incidence of all adverse events including evaluation of antidrug antibody status
时间窗: Up to 43 days after dosing
次要结局
未报告次要终点
研究者
研究点 (5)
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