- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01235988
Meta-analysis - Eltrombopag
June 6, 2017 updated by: GlaxoSmithKline
Systematic Review of the Clinical and Cost Effectiveness of Treatments for Idiopathic (Immune) Thrombocytopenic Purpura (ITP): Direct Meta Analysis
The purpose of the meta-analysis was to explore the efficacy of eltrombopag versus placebo (standard of care)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Meta-analysis of three studies: Bussell 2007 & Bussell 2009 & RAISE (TRA102537).
Study Type
Observational
Enrollment (Actual)
1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Meta-analysis: A systematic review was conducted to obtain all relevant evidence relating to eltrombopag and relevant studies were selected
Description
Inclusion Criteria:
- Adults with ITP
- Received a pre-specified treatment
- Prospective clinical studies with at least 10 patients
Exclusion Criteria:
- Subjects with ITP due to other causes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Eltrombopag & standard of care
|
Eltrombopag 50mg & standard of care
|
Standard of care
|
Placebo + standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
>=50 Gi/L platelet count to <400 Gi/L
Time Frame: 43 days
|
43 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
November 4, 2010
First Submitted That Met QC Criteria
November 4, 2010
First Posted (Estimate)
November 7, 2010
Study Record Updates
Last Update Posted (Actual)
June 7, 2017
Last Update Submitted That Met QC Criteria
June 6, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thrombocytopaenia
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GlaxoSmithKlineCompletedThrombocytopaeniaSpain, Taiwan, Bulgaria, United States, Argentina, Russian Federation, Germany, Korea, Republic of, Austria, India, Italy, United Kingdom, Poland, Romania, Ukraine, Hungary, Peru, Czech Republic, Mexico
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GlaxoSmithKlineWithdrawn
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GlaxoSmithKlineCompletedThrombocytopaeniaUnited States, Germany, Israel, Belgium, Finland, Ireland, Italy, Greece, India, Czech Republic, Hungary, Canada, Poland
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GlaxoSmithKlineCompletedThrombocytopaeniaUnited States
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GlaxoSmithKlineCompletedThrombocytopaeniaUnited States
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Novartis PharmaceuticalsCompletedThrombocytopaeniaBelgium, Greece, Netherlands, Romania, China, Korea, Republic of, Tunisia, France, Hong Kong, Ireland, Peru, Poland
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Novartis PharmaceuticalsTerminatedThrombocytopaeniaUnited States, Belgium, Australia, Canada, Hong Kong, Austria, Brazil, Czechia, Israel, Russian Federation, Spain, Sweden, Thailand, Denmark, France, Germany, Ireland, Italy, Korea, Republic of, Peru, Switzerland, Taiwan, Turkey, Hungary and more
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Novartis PharmaceuticalsCompletedThrombocytopaeniaUnited States, Belgium, Canada, Hong Kong, Argentina, Brazil, Czechia, Germany, Greece, Israel, Netherlands, Spain, Thailand, Hungary, Ireland, Italy, Mexico, Taiwan, Korea, Republic of, Poland, Russian Federation, Puerto Rico
Clinical Trials on Eltrombopag
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Novartis PharmaceuticalsCompletedPurpura, Thrombocytopenic, IdiopathicRussian Federation
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Fondazione Progetto EmatologiaCompletedChronic Lymphocytic Leukemia | Purpura, Thrombocytopenic, Idiopathic | Non Hodgkin's Lymphoma | Autoimmune Thrombocytopenia | Autoimmune Thrombocytopenic PurpuraItaly
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Weill Medical College of Cornell UniversityNovartisTerminatedImmune ThrombocytopeniaUnited States
-
Institute of Hematology & Blood Diseases Hospital...Xijing Hospital; Xi'an Central Hospital; The Second Hospital of Hebei Medical... and other collaboratorsActive, not recruitingPreviously Treated Primary Immune ThrombocytopeniaChina
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Tel-Aviv Sourasky Medical CenterNovartisRecruitingB Cell Lymphoma | CART TreatmentIsrael
-
Gruppo Italiano Malattie EMatologiche dell'AdultoCompletedPrimacy Immune ThrombocytopeniaItaly
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Novartis PharmaceuticalsCompletedPurpura, Thrombocytopaenic, Idiopathic
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Nanfang Hospital of Southern Medical UniversityGuangzhou First People's Hospital; Second Affiliated Hospital, Sun Yat-Sen... and other collaboratorsUnknownAcute Myeloid Leukemia | Thrombocytopenia | EltrombopagChina
-
IRCCS Policlinico S. MatteoCompleted