EUCTR2006-002945-36-SE进行中（未招募）不适用
ENS – Long-term Eltrombopag ObservatioNal Study - A long term observational ocular safety study in adults who have received study medication (SB-497115-GR / eltrombopag olamine or placebo) in a phase II or III clinical study evaluating eltrombopag - LENS
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 800 人开始时间: 2006年12月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
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 has signed and dated a written informed consent for this study.
- •Subject has previously participated in a study evaluating eltrombopag, either phase II or III, and must have received at least one dose of study medication (either active drug or placebo). This excludes subjects from phase I studies (see section 5.1). Subjects who have access to eltrombopag through other programs may be eligible for LENS.
- •The prescribed follow-up ophthalmic assessment at 6 months post end of treatment should be completed as specified in the protocol for the previous study.
- •Subject is able to understand and comply with protocol requirements and instructions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has received surgery for cataracts and is aphakic or bilaterally pseudophakic.
- •In some countries (i.e. France), a subject is neither affiliated with nor a beneficiary of a social security category.
研究者
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已完成
不适用
TRA108132 : LENS - Long-Term Eltrombopag Observational StudyCTRI/2009/091/000522GlaxoSmithkline Pharmaceuticals Ltd150