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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00643929




Registration number
NCT00643929
Ethics application status
Date submitted
6/03/2008
Date registered
26/03/2008
Date last updated
23/03/2017

Titles & IDs
Public title
LENS - Long-term Eltrombopag Observational Study
Scientific 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
Secondary ID [1] 0 0
TRA108132
Universal Trial Number (UTN)
Trial acronym
LENS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Purpura, Thrombocytopaenic, Idiopathic 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Eltrombopag

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


Treatment: Drugs: Eltrombopag
Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Description of the incidence of changes in lens over time
Timepoint [1] 0 0
2.5 years
Secondary outcome [1] 0 0
Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.
Timepoint [1] 0 0
2.5 years

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
164
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Plovdiv
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Sofia
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Manitoba
Country [11] 0 0
Canada
State/province [11] 0 0
Nova Scotia
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Brno
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Praha 4
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Praha 8
Country [16] 0 0
France
State/province [16] 0 0
Caen
Country [17] 0 0
France
State/province [17] 0 0
Clichy Cedex
Country [18] 0 0
France
State/province [18] 0 0
Marseille Cedex 08
Country [19] 0 0
France
State/province [19] 0 0
Paris Cedex 12
Country [20] 0 0
France
State/province [20] 0 0
Pessac Cedex
Country [21] 0 0
France
State/province [21] 0 0
Pessac
Country [22] 0 0
France
State/province [22] 0 0
Rouen cedex
Country [23] 0 0
France
State/province [23] 0 0
Vandoeuvre Les Nancy
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Shatin, New Territories
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
India
State/province [27] 0 0
Bangalore
Country [28] 0 0
India
State/province [28] 0 0
Chennai
Country [29] 0 0
India
State/province [29] 0 0
Kolkatta
Country [30] 0 0
India
State/province [30] 0 0
Mumbai
Country [31] 0 0
Italy
State/province [31] 0 0
Campania
Country [32] 0 0
Italy
State/province [32] 0 0
Lazio
Country [33] 0 0
Italy
State/province [33] 0 0
Liguria
Country [34] 0 0
Italy
State/province [34] 0 0
Lombardia
Country [35] 0 0
Italy
State/province [35] 0 0
Puglia
Country [36] 0 0
Pakistan
State/province [36] 0 0
Karachi
Country [37] 0 0
Peru
State/province [37] 0 0
Lima
Country [38] 0 0
Poland
State/province [38] 0 0
Poznan
Country [39] 0 0
Puerto Rico
State/province [39] 0 0
San Juan
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Moscow
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Saint-Petersburg
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Samara
Country [43] 0 0
Russian Federation
State/province [43] 0 0
St'Petersburg
Country [44] 0 0
Russian Federation
State/province [44] 0 0
St. Petersburg
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid
Country [47] 0 0
Spain
State/province [47] 0 0
San Sebastián
Country [48] 0 0
Spain
State/province [48] 0 0
Santa Cruz de Tenerife
Country [49] 0 0
Spain
State/province [49] 0 0
Santiago de Compostela
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla
Country [51] 0 0
Sweden
State/province [51] 0 0
Stockholm
Country [52] 0 0
Tunisia
State/province [52] 0 0
Montfleury
Country [53] 0 0
Tunisia
State/province [53] 0 0
Sfax
Country [54] 0 0
Tunisia
State/province [54] 0 0
Sousse
Country [55] 0 0
Tunisia
State/province [55] 0 0
Tunis
Country [56] 0 0
Ukraine
State/province [56] 0 0
Dnipropetrovsk
Country [57] 0 0
Ukraine
State/province [57] 0 0
Donetsk
Country [58] 0 0
Ukraine
State/province [58] 0 0
Kyiv
Country [59] 0 0
Ukraine
State/province [59] 0 0
Vinnytsia
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Devon
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Lanarkshire
Country [62] 0 0
United Kingdom
State/province [62] 0 0
London
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Morriston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00643929
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00643929