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

LENS - Long-term Eltrombopag Observational Study

Sponsors

Lead sponsor: GlaxoSmithKline

Source GlaxoSmithKline
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.

Overall Status Completed
Start Date February 2007
Completion Date March 2013
Primary Completion Date March 2013
Study Type Observational
Primary Outcome
Measure Time Frame
Description of the incidence of changes in lens over time 2.5 years
Secondary Outcome
Measure Time Frame
Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag. 2.5 years
Enrollment 164
Condition
Intervention

Intervention type: Drug

Intervention name: Eltrombopag

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

Arm group label: Observational

Other name: Promacta

Eligibility

Sampling method: Probability Sample

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.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director GlaxoSmithKline
Location
facility
GSK Investigational Site | Tucson, Arizona, 85724, United States
GSK Investigational Site | Washington, District of Columbia, 20007, United States
GSK Investigational Site | Detroit, Michigan, 48202, United States
GSK Investigational Site | Durham, North Carolina, 27710, United States
GSK Investigational Site | Richmond, Virginia, 23249, United States
GSK Investigational Site | Kogarah, New South Wales, 2217, Australia
GSK Investigational Site | Plovdiv, 4000, Bulgaria
GSK Investigational Site | Sofia, 1756, Bulgaria
GSK Investigational Site | Calgary, Alberta, T2N 4Z6, Canada
GSK Investigational Site | Victoria, British Columbia, V8V 3P9, Canada
GSK Investigational Site | Winnipeg, Manitoba, R3E 3P4, Canada
GSK Investigational Site | Halifax, Nova Scotia, B3H 2Y9, Canada
GSK Investigational Site | Montreal, Quebec, H2X 3J4, Canada
GSK Investigational Site | Brno, 656 53, Czech Republic
GSK Investigational Site | Praha 4, 140 21, Czech Republic
GSK Investigational Site | Praha 8, 180 81, Czech Republic
GSK Investigational Site | Caen, 14033, France
GSK Investigational Site | Clichy Cedex, 92118, France
GSK Investigational Site | Marseille Cedex 08, 13285, France
GSK Investigational Site | Paris Cedex 12, 75571, France
GSK Investigational Site | Pessac Cedex, 33604, France
GSK Investigational Site | Pessac, 33604, France
GSK Investigational Site | Rouen cedex, 76031, France
GSK Investigational Site | Vandoeuvre Les Nancy, 54511, France
GSK Investigational Site | Berlin, 13353, Germany
GSK Investigational Site | Shatin, New Territories, Hong Kong
GSK Investigational Site | Budapest, 1529, Hungary
GSK Investigational Site | Bangalore, India
GSK Investigational Site | Chennai, 600010, India
GSK Investigational Site | Kolkatta, 700 054, India
GSK Investigational Site | Mumbai, 400036, India
GSK Investigational Site | Avellino, Campania, 83100, Italy
GSK Investigational Site | Roma, Lazio, 00133, Italy
GSK Investigational Site | Genova, Liguria, 16132, Italy
GSK Investigational Site | Brescia, Lombardia, 25123, Italy
GSK Investigational Site | Milano, Lombardia, 20132, Italy
GSK Investigational Site | Milano, Lombardia, 20157, Italy
GSK Investigational Site | San Giovanni Rotondo, Puglia, 71013, Italy
GSK Investigational Site | Karachi, 75300, Pakistan
GSK Investigational Site | Lima, Lima 27, Peru
GSK Investigational Site | Lima, Lima 41, Peru
GSK Investigational Site | Poznan, 61-866, Poland
GSK Investigational Site | San Juan, 00909, Puerto Rico
GSK Investigational Site | Moscow, 105 229, Russian Federation
GSK Investigational Site | Moscow, 117997, Russian Federation
GSK Investigational Site | Moscow, 125167, Russian Federation
GSK Investigational Site | Saint-Petersburg, 191167, Russian Federation
GSK Investigational Site | Samara, 443011, Russian Federation
GSK Investigational Site | St'Petersburg, 191024, Russian Federation
GSK Investigational Site | St. Petersburg, 197758, Russian Federation
GSK Investigational Site | St. Petersburg, 198255, Russian Federation
GSK Investigational Site | Barcelona, 08907, Spain
GSK Investigational Site | Madrid, 28006, Spain
GSK Investigational Site | Madrid, 28034, Spain
GSK Investigational Site | San Sebastián, 20014, Spain
GSK Investigational Site | Santa Cruz de Tenerife, 38320, Spain
GSK Investigational Site | Santiago de Compostela, 15706, Spain
GSK Investigational Site | Sevilla, 41014, Spain
GSK Investigational Site | Stockholm, SE-141 86, Sweden
GSK Investigational Site | Stockholm, SE-171 76, Sweden
GSK Investigational Site | Montfleury, 1008, Tunisia
GSK Investigational Site | Sfax, 3029, Tunisia
GSK Investigational Site | Sousse, 4000, Tunisia
GSK Investigational Site | Tunis, 1008, Tunisia
GSK Investigational Site | Dnipropetrovsk, 49102, Ukraine
GSK Investigational Site | Donetsk, 83114, Ukraine
GSK Investigational Site | Kyiv, 01030, Ukraine
GSK Investigational Site | Vinnytsia, 21021, Ukraine
GSK Investigational Site | Plymouth, Devon, PL6 8DH, United Kingdom
GSK Investigational Site | Glasgow, Lanarkshire, G12 0YN, United Kingdom
GSK Investigational Site | London, NW1 2BU, United Kingdom
GSK Investigational Site | Morriston, SA6 6NL, United Kingdom
Location Countries

Australia

Bulgaria

Canada

Czech Republic

France

Germany

Hong Kong

Hungary

India

Italy

Pakistan

Peru

Poland

Puerto Rico

Russian Federation

Spain

Sweden

Tunisia

Ukraine

United Kingdom

United States

Verification Date

March 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Observational

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

Acronym LENS
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov