Purpura, Thrombocytopaenic, Idiopathic
Conditions
Keywords
thrombopoietin receptor agonist, ocular safety, HCV, SB-497115-GR, CIT, ITP, cataract, eltrombopag olamine, lens opacity
Brief summary
A long term observational ocular safety study in adults who have received study medication (either active drug or placebo) in a phase II or III clinical study evaluating eltrombopag. The study will follow subjects for 2.5 years following their last ocular assessment on their prior treatment study (regardless of the therapeutic indication) and will describe long-term ocular safety with respect to changes in the lenses over time from all subjects.
Interventions
DRUGEltrombopag
Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 (See Section 5.1). * 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.
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. * In some countries (i.e. France), a subject is neither affiliated with nor a beneficiary of a social security category.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Description of the incidence of changes in lens over time | 2.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag. | 2.5 years |
Countries
Australia, Bulgaria, Canada, Czechia, France, Germany, Hong Kong, Hungary, India, Italy, Pakistan, Peru, Poland, Puerto Rico, Russia, Spain, Sweden, Tunisia, Ukraine, United Kingdom, United States
Outcome results
None listed