NCT02868099已完成3 期
A Multi-center, Randomized, Placebo-controlled, Double-blinded Then Open 2 Stages Clinical Trial to Evaluate the Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Kyowa Kirin China Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 203 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
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Number of weeks in which the platelet response counts increase above 50×10^9/L
研究概览
简要总结
The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut subjects with persistent or chronic primary immune thrombocytopenia (ITP).
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
- Double (Participant, Investigator)
盲法说明
Placebo-controlled, Double-blinded then Open-label
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
- •Diagnosed with immune thrombocytopenia (ITP) for at least 6 months prior to signing the informed consent form (ICF).
- •Subject is ≥ 18 years old while signing the ICF.
- •Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have no response or relapse to at least 1 prior treatment for immune thrombocytopenia (ITP).
- •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 those typical of ITP.
- •Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, and no treatment or active disease within 5 years prior to signing the ICF..
- •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 myeloproliferative leukemia (MPL) stimulation product other than the subject who had suspended recombinant human thrombopoietin (rHuTPO) for injection for 4 weeks before signing 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 prior to signing the ICF.
- •Pregnant or breastfeeding.
- •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
Placebo
Placebo Comparator
Subjects received placebo for injection treatment will be administered subcutaneously once a week
干预措施: Placebo (Drug)
Drug
Experimental
Subjects received Romiplostim for injection treatment will be administered subcutaneously once a week
干预措施: Romiplostim (Drug)
结局指标
主要结局
Number of weeks in which the platelet response counts increase above 50×10^9/L
时间窗: 6 weeks
次要结局
- Proportion of subjects whose platelet counts relative to the baseline increase ≥ 20×10^9/L(6 weeks)
- Proportion of subjects who have received emergency treatment to increase the platelet counts(6 weeks)
研究者
研究点 (1)
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