Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP): Efficacy and Safety.

June 12, 2012 updated by: Khellaf Mehdi, Henri Mondor University Hospital

Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP).

TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP) who received alternatively romiplostim and eltrombopag.

Study Overview

Status

Completed

Conditions

Detailed Description

Thrombopoietin mimetics agents are available since 5 years in France through clinical trials first and then after their license. Two drugs are used: romiplostim and eltrombopag. These molecules have the same receptor on the megacaryocyte and induce the same stimulation of this cell leading to the differentiation and the proliferation into platelets. But romiplostim and eltrombopag have 2 different characteristics: the way of administration (oral for eltrombopag and subcutaneous for romiplostim) and the binding site to the C-MPL receptor on megacaryocyte. The aim of this study is to describe ITP patients who received these two drugs alternatively in order to know if there is a benefit for switching these molecules in clinical practice.

Study Type

Observational

Enrollment (Actual)

50

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

Non-Probability Sample

Study Population

Patients with primary Immune Thrombopenia receiving romiplostim and eltrombopag alternatively.

Description

Inclusion Criteria:

  • Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (Rodeghiero et al, 2009).
  • Subject is equal to or greater than 18 years of age.
  • Before any study-specific procedure, the appropriate written informed consent must be obtained.
  • Subject receiving romiplostim and eltrombopag alternatively
  • Available follow-up of 2 months at least for each period

Exclusion Criteria:

- Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia

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
Romiplostim and eltrombopag in ITP
ITP patients who received alternatively romiplostim or eltrombopag with at least two months of follow-up for each period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of efficacy after switching from one TPO mimetics to a second one.
Time Frame: 2 months minimun
The primary outcome of this study is to know if switching from one TPO mimetics to a second one in ITP patients lead to a better efficacy in a significative proportion of patients.
2 months minimun

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with an adverse events who have a benefit after switching.
Time Frame: 6 months
Some ITP patients under TPO-r mimetics have some adverse events, the secondary outcome of this study is to evaluate the benefit to switch from one TPO-r mimetics to a second one in these cases.
6 months

Collaborators and Investigators

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

Sponsor

Henri Mondor University Hospital

Collaborators

Paris 12 Val de Marne University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Estimate)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPO-r switch
  • TPO-r Switch in ITP

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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