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Indirect Comparison Between Eltrombopag & Romiplostim

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01236014
First received: November 4, 2010
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Durable response: platelet count of >=50 and <400 Gi/L [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall response: either a durable response or a transient platelet response [ Time Frame: 6 months ] [ 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 & 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236014

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: NCT01236014     History of Changes
Other Study ID Numbers: 114014
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, Thrombocytopenic, Idiopathic
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Thrombotic Microangiopathies
Blood Platelet Disorders
 Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on May 16, 2013