Last updated: 11/04/2018 12:57:43
LENS – Long-term Eltrombopag Observational StudyLENS
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Description of the incidence of changes in lens over time
Timeframe: 2.5 years
Secondary outcomes:
Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.
Timeframe: 2.5 years
Interventions:
Drug: Eltrombopag
Enrollment:
164
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Purpura, Thrombocytopaenic, Idiopathic
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
February 2007 to March 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Bangalore, India
1.3 miles (2.1 km) away from your location
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2013-07-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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