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Indirect Comparison Between Eltrombopag & Romiplostim

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ClinicalTrials.gov Identifier: NCT01236014
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
An indirect comparison to compare the efficacy of eltrombopag versus romiplostim

Condition or disease Intervention/treatment
Thrombocytopaenia Drug: Eltrombopag Drug: Romiplostim Drug: Placebo

Detailed Description:
An indirect analysis was conducted to evaluate the relative efficacy of eltrombopag and romiplostim using placebo as a common comparator

Study Type : Observational
Actual Enrollment : 1 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009


Group/Cohort Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01236014     History of Changes
Other Study ID Numbers: 114014
First Posted: November 8, 2010    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases