ENS – Long-term Eltrombopag ObservatioNal Study - A long term observational ocular safety 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 - LENS

• Conditions: MedDRA version: 14.1Level: PTClassification code 10007739Term: CataractSystem Organ Class: 10015919 - Eye disorders; ong-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)

• Registration Number: EUCTR2006-002945-36-CZ
• Lead Sponsor: GlaxoSmithKline Research and Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-04
• Last Update Posted: 16 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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..