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Completed

NCT Number: NCT00643929

LENS - Long-term Eltrombopag Observational Study

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.

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Key information

Conditions

Purpura, Thrombocytopaenic, Idiopathic Blood Coagulation Disorders Cataract Eye Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Lens Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Signs and Symptoms Skin Manifestations

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Kogarah, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eltrombopag

Drug

Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo

Other names: Promacta

Primary outcomes

  1. Description of the incidence of changes in lens over time

    Time frame: 2.5 years

Secondary outcomes

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

    Time frame: 2.5 years

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: LENS

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2008
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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