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Indirect Comparison Between Eltrombopag & Romiplostim

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236014
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
An indirect comparison to compare the efficacy of eltrombopag versus romiplostim

Condition Intervention
Thrombocytopaenia Drug: Eltrombopag Drug: Romiplostim Drug: Placebo

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Indirect Comparison of Efficacy of Treatments for Idiopathic Immune Thrombocytopenic Purpura - Review of Platelet Responses and Bleeding Events

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Durable response: platelet count of >=50 and <400 Gi/L [ Time Frame: 6 months ]
  • Overall response: either a durable response or a transient platelet response [ Time Frame: 6 months ]

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 & standard of care
Romiplostim & standard of care Drug: Romiplostim
Romiplostim & standard of care
Standard of care Drug: Placebo
Placebo & standard of care

Detailed Description:
An indirect analysis was conducted to evaluate the relative efficacy of eltrombopag and romiplostim using placebo as a common comparator
  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
Identified through a systematic review: TRA102537, Kuter 2008
Criteria

Inclusion Criteria:

  • Adults with ITP
  • Pre-specified treatment
  • Prospective clinical studies with at least 10 patients

Exclusion Criteria:

  • Adults with ITP for other reasons
  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): NCT01236014


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01236014     History of Changes
Other Study ID Numbers: 114014
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