LENS - Long-term Eltrombopag Observational Study (LENS)

March 21, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • GSK Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • GSK Investigational Site
      • Sofia, Bulgaria, 1756
        • GSK Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • GSK Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3P9
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • GSK Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 656 53
        • GSK Investigational Site
      • Praha 4, Czech Republic, 140 21
        • GSK Investigational Site
      • Praha 8, Czech Republic, 180 81
        • GSK Investigational Site
  • France
      • Caen, France, 14033
        • GSK Investigational Site
      • Clichy Cedex, France, 92118
        • GSK Investigational Site
      • Marseille Cedex 08, France, 13285
        • GSK Investigational Site
      • Paris Cedex 12, France, 75571
        • GSK Investigational Site
      • Pessac, France, 33604
        • GSK Investigational Site
      • Pessac Cedex, France, 33604
        • GSK Investigational Site
      • Rouen cedex, France, 76031
        • GSK Investigational Site
      • Vandoeuvre Les Nancy, France, 54511
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • GSK Investigational Site
  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1529
        • GSK Investigational Site
  • India
      • Bangalore, India
        • GSK Investigational Site
      • Chennai, India, 600010
        • GSK Investigational Site
      • Kolkatta, India, 700 054
        • GSK Investigational Site
      • Mumbai, India, 400036
        • GSK Investigational Site
  • Italy
    • Campania
      • Avellino, Campania, Italy, 83100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00133
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20132
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20157
        • GSK Investigational Site
    • Puglia
      • San Giovanni Rotondo, Puglia, Italy, 71013
        • GSK Investigational Site
  • Pakistan
      • Karachi, Pakistan, 75300
        • GSK Investigational Site
  • Peru
      • Lima, Peru, Lima 27
        • GSK Investigational Site
      • Lima, Peru, Lima 41
        • GSK Investigational Site
  • Poland
      • Poznan, Poland, 61-866
        • GSK Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 117997
        • GSK Investigational Site
      • Moscow, Russian Federation, 105 229
        • GSK Investigational Site
      • Moscow, Russian Federation, 125167
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 191167
        • GSK Investigational Site
      • Samara, Russian Federation, 443011
        • GSK Investigational Site
      • St'Petersburg, Russian Federation, 191024
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 198255
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 197758
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08907
        • GSK Investigational Site
      • Madrid, Spain, 28006
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • San Sebastián, Spain, 20014
        • GSK Investigational Site
      • Santa Cruz de Tenerife, Spain, 38320
        • GSK Investigational Site
      • Santiago de Compostela, Spain, 15706
        • GSK Investigational Site
      • Sevilla, Spain, 41014
        • GSK Investigational Site
  • Sweden
      • Stockholm, Sweden, SE-171 76
        • GSK Investigational Site
      • Stockholm, Sweden, SE-141 86
        • GSK Investigational Site
  • Tunisia
      • Montfleury, Tunisia, 1008
        • GSK Investigational Site
      • Sfax, Tunisia, 3029
        • GSK Investigational Site
      • Sousse, Tunisia, 4000
        • GSK Investigational Site
      • Tunis, Tunisia, 1008
        • GSK Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • GSK Investigational Site
      • Donetsk, Ukraine, 83114
        • GSK Investigational Site
      • Kyiv, Ukraine, 01030
        • GSK Investigational Site
      • Vinnytsia, Ukraine, 21021
        • GSK Investigational Site
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • GSK Investigational Site
      • Morriston, United Kingdom, SA6 6NL
        • GSK Investigational Site
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • GSK Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23249
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects who participated in a prior eltrombopag study, regardless of indication, and have received either placebo or eltrombopag.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Subjects who have participated in a prior eltrombopag study, receiving either placebo or eltrombopag
Drug: Eltrombopag
Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo
Other Names:
  • Promacta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Description of the incidence of changes in lens over time
Time Frame: 2.5 years
2.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.
Time Frame: 2.5 years
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRA108132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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