LENS - Long-term Eltrombopag Observational Study

NCT00643929 | Completed

• 1 other identifier: TRA108132
• Study Type: observational
• Target: 164
• Locations: 21 countries
• Sites: 71

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.

Conditions

Purpura, Thrombocytopaenic, Idiopathic

Keywords

thrombopoietin receptor agonist; ocular safety; HCV; SB-497115-GR; CIT; ITP; cataract; eltrombopag olamine; lens opacity

Outcome Measures

Primary Outcomes (1)

• Description of the incidence of changes in lens over time

  2.5 years

Secondary Outcomes (1)

• Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.

  2.5 years

Study Arms (1)

Observational

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

Drug: Eltrombopag

Interventions

Eltrombopag DRUG

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

Also known as: Promacta

Observational

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who participated in a prior eltrombopag study, regardless of indication, and have received either placebo or eltrombopag.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (71)

GSK Investigational Site

Tucson, Arizona, 85724, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

GSK Investigational Site

Detroit, Michigan, 48202, United States

Location

GSK Investigational Site

Durham, North Carolina, 27710, United States

Location

GSK Investigational Site

Richmond, Virginia, 23249, United States

Location

GSK Investigational Site

Kogarah, New South Wales, 2217, Australia

Location

GSK Investigational Site

Plovdiv, 4000, Bulgaria

Location

GSK Investigational Site

Sofia, 1756, Bulgaria

Location

GSK Investigational Site

Calgary, Alberta, T2N 4Z6, Canada

Location

GSK Investigational Site

Victoria, British Columbia, V8V 3P9, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3E 3P4, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2X 3J4, Canada

Location

GSK Investigational Site

Brno, 656 53, Czechia

Location

GSK Investigational Site

Prague, 140 21, Czechia

Location

GSK Investigational Site

Prague, 180 81, Czechia

Location

GSK Investigational Site

Caen, 14033, France

Location

GSK Investigational Site

Clichy, 92118, France

Location

GSK Investigational Site

Marseille, 13285, France

Location

GSK Investigational Site

Paris, 75571, France

Location

GSK Investigational Site

Pessac, 33604, France

Location

GSK Investigational Site

Rouen, 76031, France

Location

GSK Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

GSK Investigational Site

Berlin, State of Berlin, 13353, Germany

Location

GSK Investigational Site

Shatin, New Territories, Hong Kong

Location

GSK Investigational Site

Budapest, 1529, Hungary

Location

GSK Investigational Site

Bangalore, India

Location

GSK Investigational Site

Chennai, 600010, India

Location

GSK Investigational Site

Kolkata, 700 054, India

Location

GSK Investigational Site

Mumbai, 400036, India

Location

GSK Investigational Site

San Giovanni Rotondo, Apulia, 71013, Italy

Location

GSK Investigational Site

Avellino, Campania, 83100, Italy

Location

GSK Investigational Site

Rome, Lazio, 00133, Italy

Location

GSK Investigational Site

Genoa, Liguria, 16132, Italy

Location

GSK Investigational Site

Brescia, Lombardy, 25123, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20132, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20157, Italy

Location

GSK Investigational Site

Karachi, 75300, Pakistan

Location

GSK Investigational Site

Lima, Lima Province, Lima 41, Peru

Location

GSK Investigational Site

Lima, Lima 27, Peru

Location

GSK Investigational Site

Poznan, 61-866, Poland

Location

GSK Investigational Site

San Juan, Puerto Rico, 00909, Puerto Rico

Location

GSK Investigational Site

Moscow, 105 229, Russia

Location

GSK Investigational Site

Moscow, 117997, Russia

Location

GSK Investigational Site

Moscow, 125167, Russia

Location

GSK Investigational Site

Saint Petersburg, 191167, Russia

Location

GSK Investigational Site

Saint Petersburg, 197758, Russia

Location

GSK Investigational Site

Saint Petersburg, 198255, Russia

Location

GSK Investigational Site

Samara, 443011, Russia

Location

GSK Investigational Site

St'Petersburg, 191024, Russia

Location

GSK Investigational Site

Barcelona, 08907, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

San Sebastián, 20014, Spain

Location

GSK Investigational Site

Santa Cruz de Tenerife, 38320, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Seville, 41014, Spain

Location

GSK Investigational Site

Stockholm, SE-141 86, Sweden

Location

GSK Investigational Site

Stockholm, SE-171 76, Sweden

Location

GSK Investigational Site

Montfleury, 1008, Tunisia

Location

GSK Investigational Site

Sfax, 3029, Tunisia

Location

GSK Investigational Site

Sousse, 4000, Tunisia

Location

GSK Investigational Site

Tunis, 1008, Tunisia

Location

GSK Investigational Site

Dnipropetrovsk, 49102, Ukraine

Location

GSK Investigational Site

Donetsk, 83114, Ukraine

Location

GSK Investigational Site

Kyiv, 01030, Ukraine

Location

GSK Investigational Site

Vinnytsia, 21021, Ukraine

Location

GSK Investigational Site

Plymouth, Devon, PL6 8DH, United Kingdom

Location

GSK Investigational Site

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

GSK Investigational Site

London, NW1 2BU, United Kingdom

Location

GSK Investigational Site

Morriston, SA6 6NL, United Kingdom

Location

MeSH Terms

Conditions

Purpura; Cataract

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Lens Diseases; Eye Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 26, 2008
• Study Start: February 1, 2007
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 23, 2017

Record last verified: 2017-03

Locations

US (5); CA (5); RU (8); IN (4); PL (1); UA (4); PE (2); GB (4); TU (4); FR (7); PA (1); BU (2); DE (1); HU (1); ES (7); PR (1); AU (1); IT (7); SE (2); CZ (3); HK (1)