Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP): Efficacy and Safety.
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Purpose
TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP) who received alternatively romiplostim and eltrombopag.
| Condition |
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Immune Thrombocytopenia Thrombopoietin Receptor Agonist |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP). |
- Rate of efficacy after switching from one TPO mimetics to a second one. [ Time Frame: 2 months minimun ] [ Designated as safety issue: No ]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.
- Rate of patients with an adverse events who have a benefit after switching. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 50 |
| Study Start Date: | January 2012 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations More Information
No publications provided
| 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 |
| Study First Received: | June 11, 2012 |
| Last Updated: | June 12, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes |
Keywords provided by Henri Mondor University Hospital:
|
Immune Thrombocytopenia Thrombopoietin receptor agonist |
Additional relevant MeSH terms:
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Thrombocytopenia Blood Platelet Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013