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

NCT ID: NCT01618734

Last Updated: 2012-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Immune Thrombocytopenia Thrombopoietin Receptor Agonist

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Romiplostim and eltrombopag in ITP

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paris 12 Val de Marne University

OTHER

Sponsor Role collaborator

Henri Mondor University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Khellaf Mehdi

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Khellaf M, Viallard JF, Hamidou M, Cheze S, Roudot-Thoraval F, Lefrere F, Fain O, Audia S, Abgrall JF, Michot JM, Dauriac C, Lefort S, Gyan E, Niault M, Durand JM, Languille L, Boutboul D, Bierling P, Michel M, Godeau B. A retrospective pilot evaluation of switching thrombopoietic receptor-agonists in immune thrombocytopenia. Haematologica. 2013 Jun;98(6):881-7. doi: 10.3324/haematol.2012.074633. Epub 2013 Feb 26.

Reference Type DERIVED
PMID: 23445876 (View on PubMed)

Other Identifiers

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TPO-r Switch in ITP

Identifier Type: -

Identifier Source: secondary_id

TPO-r switch

Identifier Type: -

Identifier Source: org_study_id

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