TRA108132 : LENS - Long-Term Eltrombopag Observational Study
- Registration Number
- CTRI/2009/091/000522
- Lead Sponsor
- GlaxoSmithkline Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Description in the incidence of changes in the lenses over time from all consenting subjects who have previoiusly recieved study medication (either active drug or placebo) in a phase II or III eltrombopag study regardless of the therapeutic indication.Timepoint: Annual
- Secondary Outcome Measures
Name Time Method Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.<br>Timepoint: