CTRI/2009/091/000522已完成未知
TRA108132 : LENS - Long-Term Eltrombopag Observational Study - A Long Term Observational Ocular Safety Follow-up 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
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Inclusion Criteria:
- •Subjects are eligible for enrolment in the study if they have previously participated in an eltrombopag study, either phase II or III, and meet all of the following criteria:
- •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.
- •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.
排除标准
- •Exclusion Criteria:
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •Subject has received surgery for cataracts and is aphakic or bilaterally pseudophakic.
研究者
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