Meta-analysis - Eltrombopag

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01235988
First received: November 4, 2010
Last updated: November 3, 2011
Last verified: November 2011
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235988

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01235988     History of Changes
Other Study ID Numbers: 114013
Study First Received: November 4, 2010
Last Updated: November 3, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Thrombocytopenia
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014