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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01618734

Enrollment

Registered

2012-06-13

Start date

2012-01-31

Completion date

2012-06-30

Last updated

2012-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenia, Thrombopoietin Receptor Agonist

Keywords

Immune Thrombocytopenia, Thrombopoietin receptor agonist

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results