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LENS - Long-term Eltrombopag Observational Study (LENS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00643929
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Purpura, Thrombocytopaenic, Idiopathic Drug: Eltrombopag

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Study Type : Observational
Actual Enrollment : 164 participants
Observational Model: Cohort
Time Perspective: 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
Study Start Date : February 2007
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Eltrombopag

Group/Cohort Intervention/treatment
Observational
Subjects who have participated in a prior eltrombopag study, receiving either placebo or eltrombopag
Drug: Eltrombopag
Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo
Other Name: Promacta




Primary Outcome Measures :
  1. Description of the incidence of changes in lens over time [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag. [ Time Frame: 2.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who participated in a prior eltrombopag study, regardless of indication, and have received either placebo or eltrombopag.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643929


Locations
Show Show 72 study locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00643929    
Other Study ID Numbers: TRA108132
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Keywords provided by GlaxoSmithKline:
thrombopoietin receptor agonist
ocular safety
HCV
SB-497115-GR
CIT
ITP
cataract
eltrombopag olamine
lens opacity
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases