LENS - Long-term Eltrombopag Observational Study 


Tracking Information

Start Date  ICMJEMarch 2007
Estimated Primary Completion DateApril 2013   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
Original Primary Outcome Measures ICMJE 
Change HistoryComplete list of historical versions of study NCT00643929 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: March 18, 2008)		Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJELENS - Long-term Eltrombopag Observational Study
Official Title  ICMJELENS - 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
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 
Study Phase 
Study Type  ICMJEObservational
Study Design  ICMJEProspective
Condition  ICMJEOcular Safety
Intervention  ICMJEDrug: Observational Study
Other Name: Observational Study

Recruitment Information

Estimated Enrollment  ICMJE150
Estimated Completion DateApril 2013
Estimated Primary Completion DateApril 2013   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages 
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center877-379-3718
Location Countries  ICMJEUnited States,   Australia,   Canada,   Czech Republic,   France,   Germany,   Hong Kong,   Hungary,   India,   Pakistan,   Peru,   Poland,   Puerto Rico,   Russian Federation,   Spain,   Sweden,   Tunisia,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00643929
Responsible PartyStudy Director, GSK
Study ID Numbers  ICMJETRA108132
Study Sponsor  ICMJEGlaxoSmithKline
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:GSK Clinical Trials, MD, PHDGlaxoSmithKline
Information Provided ByGlaxoSmithKline