Indirect Comparison Between Eltrombopag & Romiplostim

June 6, 2017 updated by: GlaxoSmithKline

Indirect Comparison of Efficacy of Treatments for Idiopathic Immune Thrombocytopenic Purpura - Review of Platelet Responses and Bleeding Events

An indirect comparison to compare the efficacy of eltrombopag versus romiplostim

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Identified through a systematic review: TRA102537, Kuter 2008

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Adults with ITP for other reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

November 4, 2010

First Submitted That Met QC Criteria

November 4, 2010

First Posted (ESTIMATE)

November 7, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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