LENS - Long-Term Eltrombopag Observational Study - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00643929

Purpose

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	Intervention
Ocular Safety	Drug: Observational Study

Drug Information available for: Eltrombopag Olamine

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

Further study details as provided by GlaxoSmithKline:

Secondary Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	March 2007
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643929

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 92 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PHD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TRA108132
Study First Received:	March 6, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00643929
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

ITP
HCV
CIT
eltrombopag olamine
SB-497115-GR

thrombopoietin receptor agonist
lens opacity
cataract
ocular safety

Study placed in the following topic categories:

Cataract

ClinicalTrials.gov processed this record on January 16, 2009