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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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