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

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ClinicalTrials.gov Identifier: NCT01618734
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : June 13, 2012
Paris 12 Val de Marne University
Information provided by (Responsible Party):
Khellaf Mehdi, 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.

Condition or disease
Immune Thrombocytopenia Thrombopoietin Receptor Agonist

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
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

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 :
  1. 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 :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary Immune Thrombopenia receiving romiplostim and eltrombopag alternatively.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Khellaf Mehdi, Medical Doctor, Henri Mondor University Hospital
ClinicalTrials.gov Identifier: NCT01618734     History of Changes
Other Study ID Numbers: TPO-r switch
TPO-r Switch in ITP
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Khellaf Mehdi, Henri Mondor University Hospital:
Immune Thrombocytopenia
Thrombopoietin receptor agonist

Additional relevant MeSH terms:
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms