Immune ThrombocytopeniaNCT01618734
Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP): Efficacy and Safety.
An observational study of Immune Thrombocytopenia and Thrombopoietin Receptor Agonist, run by Henri Mondor University Hospital.
Trial summary
TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP) who received alternatively romiplostim and eltrombopag. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia, Thrombopoietin Receptor Agonist
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary Immune Thrombopenia receiving romiplostim and eltrombopag alternatively.
Who may be able to join
- 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
Who cannot join
- Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia
About this study
Official title: Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP).
TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP) who received alternatively romiplostim and eltrombopag.
Read the 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.
- Keywords
- Immune Thrombocytopenia, Thrombopoietin receptor agonist
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim and eltrombopag in ITP | ITP patients who received alternatively romiplostim or eltrombopag with at least two months of follow-up for each period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months minimun
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Paris 12 Val de Marne University
- Responsible party
- Principal investigator, Khellaf Mehdi, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618734
- Sponsor's protocol ID
- TPO-r switch
- Other IDs
- TPO-r Switch in ITP
- Status last verified
- Jun 2012
- First submitted
- 11 Jun 2012
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23445876
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP).
- ClinicalTrials.gov ID
- NCT01618734
- Acronym / sponsor ID
- TPO-r switch
- Keywords
- Immune Thrombocytopenia, Thrombopoietin receptor agonist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Collaborators
- Paris 12 Val de Marne University
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Romiplostim and eltrombopag in ITP | – | –ITP patients who received alternatively romiplostim or eltrombopag with at least two months of follow-up for each period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary Immune Thrombopenia receiving romiplostim and eltrombopag alternatively.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Rate of patients with an adverse events who have a benefit after switching.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
- Derived from this study: PubMed 23445876Khellaf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia and Thrombopoietin Receptor Agonist, run by Henri Mondor University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of efficacy after switching from one TPO mimetics to a second one. (time frame: 2 months minimun). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01618734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.