LENS - Long-term Eltrombopag Observational Study

Completed

• Conditions: Purpura, Thrombocytopaenic, Idiopathic
• Interventions: Drug: Eltrombopag

• Registration Number: NCT00643929
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-26
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Eltrombopag	Subjects who have participated in a prior eltrombopag study, receiving either placebo or eltrombopag

Primary Outcome Measures

Name	Time	Method
Description of the incidence of changes in lens over time	2.5 years

Secondary Outcome Measures

Name	Time	Method
Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.	2.5 years

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Morriston, United Kingdom