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Meta-analysis - Eltrombopag

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235988
First Posted: November 8, 2010
Last Update Posted: June 7, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of the meta-analysis was to explore the efficacy of eltrombopag versus placebo (standard of care)

Condition Intervention
Thrombocytopaenia Drug: Eltrombopag Drug: Placebo

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Systematic Review of the Clinical and Cost Effectiveness of Treatments for Idiopathic (Immune) Thrombocytopenic Purpura (ITP): Direct Meta Analysis

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • >=50 Gi/L platelet count to <400 Gi/L [ Time Frame: 43 days ]

Enrollment: 1
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Eltrombopag & standard of care Drug: Eltrombopag
Eltrombopag 50mg & standard of care
Standard of care Drug: Placebo
Placebo + standard of care

Detailed Description:
Meta-analysis of three studies: Bussell 2007 & Bussell 2009 & RAISE (TRA102537).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
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): NCT01235988


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01235988     History of Changes
Other Study ID Numbers: 114013
First Submitted: November 4, 2010
First Posted: November 8, 2010
Last Update Posted: June 7, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases