Long-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: 8.1 Level: LLT Classification code 10007739 Term: Cataract
Conditions
Interventions
Pharmaceutical Form:
Sponsors
GlaxoSmithKline Research and Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 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
Exclusion criteria
Exclusion criteria: 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 |
|---|---|
| Main Objective: To describe long-term ocular safety with respect to cataract formation from all consenting subjects who have received study medication (either active drug or placebo) in a phase II or III eltrombopag study regardless of the therapeutic indication.;Secondary Objective: None;Primary end point(s): To describe long-term ocular safety with respect to changes in the lenses over time from all consenting subjects who have previously received study medication (either active drug or placebo) in a phase II or III eltrombopag study regardless of the therapeutic indication.. | — |
Countries
Czech Republic, France, Spain, Sweden, United Kingdom
Outcome results
None listed