EUCTR2006-002945-36-ES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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 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
相似试验
进行中（未招募）
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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 - LENSong-term ocular safety specifically related to cataract formation in subjects who have previously participated in a phase II or III protocol for eltrombopag (SB-497715-GR)MedDRA version: 14.1Level: PTClassification code 10007739Term: CataractSystem Organ Class: 10015919 - Eye disordersEUCTR2006-002945-36-CZGlaxoSmithKline Research and Development Ltd800
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 - LENSEUCTR2006-002945-36-SEGlaxoSmithKline Research and Development Ltd800
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 - LENSEUCTR2006-002945-36-FRGlaxoSmithKline Research and Development Ltd
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 - LENSong-term ocular safety specifically related to cataract formation in subjects who have previously participated in a phase II or III protocol for eltrombopag (SB-497715-GR)MedDRA version: 13.1 Level: PT Classification code 10007739 Term: Cataract System Organ Class: 10015919 - Eye disordersEUCTR2006-002945-36-GBGlaxoSmithKline Research and Development Ltd
已完成
不适用
TRA108132 : LENS - Long-Term Eltrombopag Observational StudyCTRI/2009/091/000522GlaxoSmithkline Pharmaceuticals Ltd150