Clincosm LogoSign in Get a demo

LENS - Long-term Eltrombopag Observational Study

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00643929
Collaborator
(none)
164
Enrollment
72
Locations
72.9
Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
164 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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 Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Description of the incidence of changes in lens over time [2.5 years]

    Secondary Outcome Measures

    1. Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag. [2.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Tucson Arizona United States 85724
    2 GSK Investigational Site Washington District of Columbia United States 20007
    3 GSK Investigational Site Detroit Michigan United States 48202
    4 GSK Investigational Site Durham North Carolina United States 27710
    5 GSK Investigational Site Richmond Virginia United States 23249
    6 GSK Investigational Site Kogarah New South Wales Australia 2217
    7 GSK Investigational Site Plovdiv Bulgaria 4000
    8 GSK Investigational Site Sofia Bulgaria 1756
    9 GSK Investigational Site Calgary Alberta Canada T2N 4Z6
    10 GSK Investigational Site Victoria British Columbia Canada V8V 3P9
    11 GSK Investigational Site Winnipeg Manitoba Canada R3E 3P4
    12 GSK Investigational Site Halifax Nova Scotia Canada B3H 2Y9
    13 GSK Investigational Site Montreal Quebec Canada H2X 3J4
    14 GSK Investigational Site Brno Czech Republic 656 53
    15 GSK Investigational Site Praha 4 Czech Republic 140 21
    16 GSK Investigational Site Praha 8 Czech Republic 180 81
    17 GSK Investigational Site Caen France 14033
    18 GSK Investigational Site Clichy Cedex France 92118
    19 GSK Investigational Site Marseille Cedex 08 France 13285
    20 GSK Investigational Site Paris Cedex 12 France 75571
    21 GSK Investigational Site Pessac Cedex France 33604
    22 GSK Investigational Site Pessac France 33604
    23 GSK Investigational Site Rouen cedex France 76031
    24 GSK Investigational Site Vandoeuvre Les Nancy France 54511
    25 GSK Investigational Site Berlin Germany 13353
    26 GSK Investigational Site Shatin, New Territories Hong Kong
    27 GSK Investigational Site Budapest Hungary 1529
    28 GSK Investigational Site Bangalore India
    29 GSK Investigational Site Chennai India 600010
    30 GSK Investigational Site Kolkatta India 700 054
    31 GSK Investigational Site Mumbai India 400036
    32 GSK Investigational Site Avellino Campania Italy 83100
    33 GSK Investigational Site Roma Lazio Italy 00133
    34 GSK Investigational Site Genova Liguria Italy 16132
    35 GSK Investigational Site Brescia Lombardia Italy 25123
    36 GSK Investigational Site Milano Lombardia Italy 20132
    37 GSK Investigational Site Milano Lombardia Italy 20157
    38 GSK Investigational Site San Giovanni Rotondo Puglia Italy 71013
    39 GSK Investigational Site Karachi Pakistan 75300
    40 GSK Investigational Site Lima Peru Lima 27
    41 GSK Investigational Site Lima Peru Lima 41
    42 GSK Investigational Site Poznan Poland 61-866
    43 GSK Investigational Site San Juan Puerto Rico 00909
    44 GSK Investigational Site Moscow Russian Federation 105 229
    45 GSK Investigational Site Moscow Russian Federation 117997
    46 GSK Investigational Site Moscow Russian Federation 125167
    47 GSK Investigational Site Saint-Petersburg Russian Federation 191167
    48 GSK Investigational Site Samara Russian Federation 443011
    49 GSK Investigational Site St'Petersburg Russian Federation 191024
    50 GSK Investigational Site St. Petersburg Russian Federation 197758
    51 GSK Investigational Site St. Petersburg Russian Federation 198255
    52 GSK Investigational Site Barcelona Spain 08907
    53 GSK Investigational Site Madrid Spain 28006
    54 GSK Investigational Site Madrid Spain 28034
    55 GSK Investigational Site San Sebastián Spain 20014
    56 GSK Investigational Site Santa Cruz de Tenerife Spain 38320
    57 GSK Investigational Site Santiago de Compostela Spain 15706
    58 GSK Investigational Site Sevilla Spain 41014
    59 GSK Investigational Site Stockholm Sweden SE-141 86
    60 GSK Investigational Site Stockholm Sweden SE-171 76
    61 GSK Investigational Site Montfleury Tunisia 1008
    62 GSK Investigational Site Sfax Tunisia 3029
    63 GSK Investigational Site Sousse Tunisia 4000
    64 GSK Investigational Site Tunis Tunisia 1008
    65 GSK Investigational Site Dnipropetrovsk Ukraine 49102
    66 GSK Investigational Site Donetsk Ukraine 83114
    67 GSK Investigational Site Kyiv Ukraine 01030
    68 GSK Investigational Site Vinnytsia Ukraine 21021
    69 GSK Investigational Site Plymouth Devon United Kingdom PL6 8DH
    70 GSK Investigational Site Glasgow Lanarkshire United Kingdom G12 0YN
    71 GSK Investigational Site London United Kingdom NW1 2BU
    72 GSK Investigational Site Morriston United Kingdom SA6 6NL

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00643929
    Other Study ID Numbers:
    • TRA108132
    First Posted:
    Mar 26, 2008
    Last Update Posted:
    Mar 23, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by GlaxoSmithKline
    thrombopoietin receptor agonist
    ocular safety
    HCV
    SB-497115-GR
    CIT
    ITP
    cataract
    eltrombopag olamine
    lens opacity
    Additional relevant MeSH terms:
    Purpura
    Purpura, Thrombocytopenic
    Purpura, Thrombocytopenic, Idiopathic

    Study Results

    No Results Posted as of Mar 23, 2017