Last updated: 11/04/2018 12:57:43

LENS – Long-term Eltrombopag Observational StudyLENS

GSK study ID
TRA108132
See study documents
Clinicaltrials.gov ID
NCT00643929
EudraCT ID
2006-002945-36
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: LENS – 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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Description of the incidence of changes in lens over time

Timeframe: 2.5 years

Secondary outcomes:

Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.

Timeframe: 2.5 years

Interventions:
  • Drug: Eltrombopag
    • Enrollment:
    164
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Purpura, Thrombocytopaenic, Idiopathic
    Product
    eltrombopag
    Collaborators
    Not applicable
    Study date(s)
    February 2007 to March 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • 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.
    • 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.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Winnipeg, Manitoba, Canada, R3E 3P4
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pessac Cedex, France, 33604
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Avellino, Campania, Italy, 83100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    STOCKHOLM, Sweden, SE-141 86
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85724
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Sousse, Tunisia, 4000
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 71 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-07-03

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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