LENS - Long-term Eltrombopag Observational Study

Purpura, Thrombocytopaenic, Idiopathic Clinical Trial

— LENS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643929
• Other study ID #: TRA108132
• Status: Completed
• Phase: N/A
• First received: March 6, 2008
• Last updated: March 21, 2017
• Start date: February 2007
• Est. completion date: March 2013

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopaenic, Idiopathic
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• Eltrombopag
Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Kogarah	New South Wales
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Sofia
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Winnipeg	Manitoba
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Praha 4
Czech Republic	GSK Investigational Site	Praha 8
France	GSK Investigational Site	Caen
France	GSK Investigational Site	Clichy Cedex
France	GSK Investigational Site	Marseille Cedex 08
France	GSK Investigational Site	Paris Cedex 12
France	GSK Investigational Site	Pessac
France	GSK Investigational Site	Pessac Cedex
France	GSK Investigational Site	Rouen cedex
France	GSK Investigational Site	Vandoeuvre Les Nancy
Germany	GSK Investigational Site	Berlin
Hong Kong	GSK Investigational Site	Shatin, New Territories
Hungary	GSK Investigational Site	Budapest
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Chennai
India	GSK Investigational Site	Kolkatta
India	GSK Investigational Site	Mumbai
Italy	GSK Investigational Site	Avellino	Campania
Italy	GSK Investigational Site	Brescia	Lombardia
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	San Giovanni Rotondo	Puglia
Pakistan	GSK Investigational Site	Karachi
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Poland	GSK Investigational Site	Poznan
Puerto Rico	GSK Investigational Site	San Juan
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	St'Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	San Sebastián
Spain	GSK Investigational Site	Santa Cruz de Tenerife
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Sevilla
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
Tunisia	GSK Investigational Site	Montfleury
Tunisia	GSK Investigational Site	Sfax
Tunisia	GSK Investigational Site	Sousse
Tunisia	GSK Investigational Site	Tunis
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Vinnytsia
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Morriston
United Kingdom	GSK Investigational Site	Plymouth	Devon
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the incidence of changes in lens over time		2.5 years
Secondary	Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.		2.5 years