NCT00508820已完成3 期
An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 407
- 主要终点
- Adverse Events
研究概览
简要总结
This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are > 50,000.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years of age
- •Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines
- •If Subject is > 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP
- •Subject has received at least 1 prior therapy for ITP
- •Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is uncontrolled with conventional therapies
- •Subject (or legally-acceptable representative) is willing and able to provide written informed consent
排除标准
- •Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
- •Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product
- •Subject has a known hypersensitivity to any recombinant E coli-derived product
- •Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening
- •Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
- •Subject is pregnant or breast feeding
- •Investigator has concerns regarding the subject's ability to comply with the protocol procedures
结局指标
主要结局
Adverse Events
时间窗: Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.
One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once
次要结局
- Platelet Response (Definition 2)(Duration of treatment (up to 201 weeks))
- Platelet Response (Definition 1)(Duration of treatment (up to 201 weeks))
研究者
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