Status:
COMPLETED
LENS - Long-term Eltrombopag Observational Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Purpura, Thrombocytopaenic, Idiopathic
Eligibility:
All Genders
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00643929
Start Date
February 1 2007
End Date
March 1 2013
Last Update
March 23 2017
Active Locations (71)
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1
GSK Investigational Site
Tucson, Arizona, United States, 85724
2
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20007
3
GSK Investigational Site
Detroit, Michigan, United States, 48202
4
GSK Investigational Site
Durham, North Carolina, United States, 27710