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).

Sponsors

Lead Sponsor: Henri Mondor University Hospital

Collaborator: Paris 12 Val de Marne University

Source 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.

Overall Status Completed
Start Date January 2012
Completion Date June 2012
Primary Completion Date June 2012
Study Type Observational
Primary Outcome
Measure Time Frame
Rate of efficacy after switching from one TPO mimetics to a second one. 2 months minimun
Secondary Outcome
Measure Time Frame
Rate of patients with an adverse events who have a benefit after switching. 6 months
Enrollment 50
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Verification Date

June 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Henri Mondor University Hospital

Investigator Full Name: Khellaf Mehdi

Investigator Title: Medical Doctor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Romiplostim and eltrombopag in ITP

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

Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov