EUCTR2006-002945-36-GB进行中（未招募）1 期
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 0 人开始时间: 2007年10月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
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 healthy volunteers and patients from phase I studies who received a single dose of active drug or very low exposure (see Section 4.1).
- •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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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 - LENSEUCTR2006-002945-36-SEGlaxoSmithKline Research and Development Ltd800
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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 - LENSEUCTR2006-002945-36-FRGlaxoSmithKline Research and Development Ltd
已完成
不适用
TRA108132 : LENS - Long-Term Eltrombopag Observational StudyCTRI/2009/091/000522GlaxoSmithkline Pharmaceuticals Ltd150