LENS - Long-term Eltrombopag Observational Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Purpura, Thrombocytopaenic, Idiopathic

Intervention / Treatment
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* Drug: Eltrombopag


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Subjects who have participated in a prior eltrombopag study, receiving either placebo or eltrombopag | Drug: Eltrombopag<br>* Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo<br>* Other names: Promacta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the incidence of changes in lens over time |  | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag. |  | 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thrombopoietin receptor agonist, ocular safety, HCV, SB-497115-GR, CIT, ITP, cataract, eltrombopag olamine, lens opacity