LENS - Long-term Eltrombopag Observational Study

NCT ID: NCT00643929

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Purpura, Thrombocytopaenic, Idiopathic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Subjects who have participated in a prior eltrombopag study, receiving either placebo or eltrombopag

Eltrombopag

Intervention Type DRUG

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

Interventions

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Eltrombopag

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

Intervention Type DRUG

Other Intervention Names

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Promacta

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Tucson, Arizona, United States

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Washington D.C., District of Columbia, United States

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Detroit, Michigan, United States

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Durham, North Carolina, United States

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Richmond, Virginia, United States

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Kogarah, New South Wales, Australia

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Calgary, Alberta, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Montreal, Quebec, Canada

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Brno, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Caen, , France

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Clichy, , France

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Marseille, , France

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Paris, , France

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Pessac, , France

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Rouen, , France

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Vandœuvre-lès-Nancy, , France

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Berlin, State of Berlin, Germany

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Shatin, New Territories, , Hong Kong

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Budapest, , Hungary

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Bangalore, , India

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Chennai, , India

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Kolkata, , India

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Mumbai, , India

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San Giovanni Rotondo, Apulia, Italy

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Avellino, Campania, Italy

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Rome, Lazio, Italy

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Genoa, Liguria, Italy

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Brescia, Lombardy, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Karachi, , Pakistan

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Lima, Lima Province, Peru

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Lima, , Peru

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Poznan, , Poland

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San Juan, Puerto Rico, Puerto Rico

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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St'Petersburg, , Russia

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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San Sebastián, , Spain

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Santa Cruz de Tenerife, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Stockholm, , Sweden

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Stockholm, , Sweden

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Montfleury, , Tunisia

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Sfax, , Tunisia

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Sousse, , Tunisia

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Tunis, , Tunisia

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kyiv, , Ukraine

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Vinnytsia, , Ukraine

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Plymouth, Devon, United Kingdom

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Glasgow, Lanarkshire, United Kingdom

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London, , United Kingdom

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Morriston, , United Kingdom

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Countries

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United States Australia Bulgaria Canada Czechia France Germany Hong Kong Hungary India Italy Pakistan Peru Poland Puerto Rico Russia Spain Sweden Tunisia Ukraine United Kingdom

Other Identifiers

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TRA108132

Identifier Type: -

Identifier Source: org_study_id

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