Clinical trial NCT00643929: LENS - Long-term Eltrombopag Observational Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: thrombopoietin receptor agonist
ocular safety
HCV
SB-497115-GR
CIT
ITP
cataract
eltrombopag olamine
lens opacity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who participated in a prior eltrombopag study, regardless of indication, and have received either placebo or eltrombopag.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Description of the incidence of changes in lens over time
timeFrame: 2.5 years
Secondary outcomes:
measure: Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Kogarah
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Victoria
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Praha 4
country: Czech Republic
facility: GSK Investigational Site
city: Praha 8
country: Czech Republic
facility: GSK Investigational Site
city: Caen
country: France
facility: GSK Investigational Site
city: Clichy Cedex
country: France
facility: GSK Investigational Site
city: Marseille Cedex 08
country: France
facility: GSK Investigational Site
city: Paris Cedex 12
country: France
facility: GSK Investigational Site
city: Pessac Cedex
country: France
facility: GSK Investigational Site
city: Pessac
country: France
facility: GSK Investigational Site
city: Rouen cedex
country: France
facility: GSK Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Shatin, New Territories
country: Hong Kong
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Kolkatta
country: India
facility: GSK Investigational Site
city: Mumbai
country: India
facility: GSK Investigational Site
city: Avellino
country: Italy
facility: GSK Investigational Site
state: Campania
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Brescia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: San Giovanni Rotondo
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Karachi
country: Pakistan
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Samara
country: Russian Federation
facility: GSK Investigational Site
city: St'Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: San Sebastián
country: Spain
facility: GSK Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Montfleury
country: Tunisia
facility: GSK Investigational Site
city: Sfax
country: Tunisia
facility: GSK Investigational Site
city: Sousse
country: Tunisia
facility: GSK Investigational Site
city: Tunis
country: Tunisia
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Vinnytsia
country: Ukraine
facility: GSK Investigational Site
city: Plymouth
country: United Kingdom
facility: GSK Investigational Site
state: Devon
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Morriston
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: