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

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618734
• Other study ID #: TPO-r switch
• Secondary ID: TPO-r Switch in
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: June 12, 2012
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Henri Mondor University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis
• Thrombopoietin Receptor Agonist

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Henri Mondor University Hospital	Paris 12 Val de Marne University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of efficacy after switching from one TPO mimetics to a second one.	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.	2 months minimun	No
Secondary	Rate of patients with an adverse events who have a benefit after switching.	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.	6 months	Yes