Purpura, Thrombocytopaenic, IdiopathicLENSNCT00643929
LENS - Long-term Eltrombopag Observational Study
An observational study of Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 71 sites in 21 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Purpura, Thrombocytopaenic, Idiopathic
- What is being tested?
- Eltrombopag
- How many people
- 164 participants
- Where
- 71 sitesin 21 countries
- Study dates
- Feb 2007to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who participated in a prior eltrombopag study, regardless of indication, and have received either placebo or eltrombopag.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
71 sites in 21 countries.
71 sites in 21 countries
Russia8 sites
GSK Investigational Site
Moscow, 105 229
GSK Investigational Site
Moscow, 117997
GSK Investigational Site
Moscow, 125167
GSK Investigational Site
Saint Petersburg, 191167
GSK Investigational Site
Saint Petersburg, 197758
GSK Investigational Site
Saint Petersburg, 198255
GSK Investigational Site
Samara, 443011
GSK Investigational Site
St'Petersburg, 191024
France7 sites
GSK Investigational Site
Caen, 14033
GSK Investigational Site
Clichy, 92118
GSK Investigational Site
Marseille, 13285
GSK Investigational Site
Paris, 75571
GSK Investigational Site
Pessac, 33604
GSK Investigational Site
Rouen, 76031
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511
Italy7 sites
GSK Investigational Site
Avellino, Campania, 83100
GSK Investigational Site
Brescia, Lombardy, 25123
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Milan, Lombardy, 20132
GSK Investigational Site
Milan, Lombardy, 20157
GSK Investigational Site
Rome, Lazio, 00133
GSK Investigational Site
San Giovanni Rotondo, Apulia, 71013
Spain7 sites
GSK Investigational Site
Barcelona, 08907
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
San Sebastián, 20014
GSK Investigational Site
Santa Cruz de Tenerife, 38320
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41014
United States5 sites
GSK Investigational Site
Detroit, Michigan, 48202
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Richmond, Virginia, 23249
GSK Investigational Site
Tucson, Arizona, 85724
GSK Investigational Site
Washington D.C., District of Columbia, 20007
Canada5 sites
GSK Investigational Site
Calgary, Alberta, T2N 4Z6
GSK Investigational Site
Halifax, Nova Scotia, B3H 2Y9
GSK Investigational Site
Montreal, Quebec, H2X 3J4
GSK Investigational Site
Victoria, British Columbia, V8V 3P9
GSK Investigational Site
Winnipeg, Manitoba, R3E 3P4
India4 sites
GSK Investigational Site
Bangalore
GSK Investigational Site
Chennai, 600010
GSK Investigational Site
Kolkata, 700 054
GSK Investigational Site
Mumbai, 400036
Tunisia4 sites
GSK Investigational Site
Montfleury, 1008
GSK Investigational Site
Sfax, 3029
GSK Investigational Site
Sousse, 4000
GSK Investigational Site
Tunis, 1008
Ukraine4 sites
GSK Investigational Site
Dnipropetrovsk, 49102
GSK Investigational Site
Donetsk, 83114
GSK Investigational Site
Kyiv, 01030
GSK Investigational Site
Vinnytsia, 21021
United Kingdom4 sites
GSK Investigational Site
Glasgow, Lanarkshire, G12 0YN
GSK Investigational Site
London, NW1 2BU
GSK Investigational Site
Morriston, SA6 6NL
GSK Investigational Site
Plymouth, Devon, PL6 8DH
Czechia3 sites
GSK Investigational Site
Brno, 656 53
GSK Investigational Site
Prague, 140 21
GSK Investigational Site
Prague, 180 81
Bulgaria2 sites
GSK Investigational Site
Plovdiv, 4000
GSK Investigational Site
Sofia, 1756
Peru2 sites
GSK Investigational Site
Lima, Lima Province, Lima 41
GSK Investigational Site
Lima, Lima 27
Sweden2 sites
GSK Investigational Site
Stockholm, SE-141 86
GSK Investigational Site
Stockholm, SE-171 76
About this study
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
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
- Being tested
- Eltrombopag
- Keywords
- thrombopoietin receptor agonist, ocular safety, HCV, SB-497115-GR, CIT, ITP, cataract, eltrombopag olamine, lens opacity
- Medical subject headings
- Purpura, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
Also called Promacta
Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo
| Study group | Role | What they receive |
|---|---|---|
| Observational | Subjects who have participated in a prior eltrombopag study, receiving either placebo or eltrombopag Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the incidence of changes in lens over time
Measured: 2.5 years
Secondary outcomes (1)
Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startFeb 2007
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Purpura, Thrombocytopaenic, IdiopathicStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643929
- Sponsor's protocol ID
- TRA108132
- Acronym
- LENS
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2008
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00643929
- Acronym / sponsor ID
- LENS / TRA108132
- Conditions
- Purpura, Thrombocytopaenic, Idiopathic
- Keywords
- thrombopoietin receptor agonist, ocular safety, HCV, SB-497115-GR, CIT, ITP, cataract, eltrombopag olamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Drug: EltrombopagSubjects who have participated in a prior eltrombopag study, receiving either placebo or eltrombopag |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who participated in a prior eltrombopag study, regardless of indication, and have received either placebo or eltrombopag.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EltrombopagAlso: PromactaSubjects participated in a prior eltrombopag study, having received either eltrombopag or placebo | Drug | Observational |
Primary outcome
Description of the incidence of changes in lens over time
Time frame: 2.5 years
1 secondary outcome
Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag.
Time frame: 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
71 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 71 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in Russia, France, Italy, Spain, United States and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the incidence of changes in lens over time (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.