EUCTR2009-016203-32-Outside-EU/EEA进行中（未招募）不适用
An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura (ITP)
Amgen Inc.0 个研究点目标入组 78 人开始时间: 2014年9月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject or subject’s legally acceptable representative has provided informed consent (and assent where required) prior to any study-specific procedure.
- •Subject completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with ITP.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 78
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has or previously had any bone marrow stem cell disorder (any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study).
- •Subject has any new active malignancy diagnosed since enrollment in the previous romiplostim ITP study.
- •Subject received any alkylating agents within four weeks before the screening visit or anticipated use during the time of the proposed study.
- •Other investigational medications are excluded.
- •Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) (with the exception of romiplostim in a previous clinical study).
- •Female subject of child bearing potential (defined as having first menses) is not willing to use highly effective contraception during treatment and for 4 weeks after the end of treatment.
- •Female subject is pregnant or breast feeding, or planning to become pregnant within 4 weeks after the end of treatment.
- •Subject has known sensitivity to any of the products to be administered during dosing.
- •Subject previously has entered this study.
- •Subject will not be available for protocol-required study visits, to the best of the subject and investigator’s knowledge.
- •Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
研究者
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