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

Completed

• Conditions: Immune Thrombocytopenia; Thrombopoietin Receptor Agonist

• Registration Number: NCT01618734
• Lead Sponsor: Henri Mondor University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2012-01
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-12
• Last Update Submitted: 2012-06-12
• Study First Posted: 2012-06-13
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of efficacy after switching from one TPO mimetics to a second one.	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

Name	Time	Method
Rate of patients with an adverse events who have a benefit after switching.	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.