Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP): Efficacy and Safety.
|ClinicalTrials.gov Identifier: NCT01618734|
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : June 13, 2012
Henri Mondor University Hospital
Paris 12 Val de Marne University
Information provided by (Responsible Party):
Khellaf Mehdi, Henri Mondor University Hospital
TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP) who received alternatively romiplostim and eltrombopag.
|Condition or disease|
|Immune Thrombocytopenia Thrombopoietin Receptor Agonist|
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|
|Actual Enrollment :||50 participants|
|Official Title:||Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP).|
|Study Start Date :||January 2012|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
Resource links provided by the National Library of Medicine
Genetic and Rare Diseases Information Center resources: Idiopathic Thrombocytopenic Purpura Immune ThrombocytopeniaU.S. FDA Resources
Romiplostim and eltrombopag in ITP
ITP patients who received alternatively romiplostim or eltrombopag with at least two months of follow-up for each period.
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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