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

This study has been completed.
Sponsor:
Collaborator:
Paris 12 Val de Marne University
Information provided by (Responsible Party):
Khellaf Mehdi, Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT01618734
First received: June 11, 2012
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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


Condition
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).

Resource links provided by NLM:


Further study details as provided by Henri Mondor University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Romiplostim and eltrombopag in ITP
ITP patients who received alternatively romiplostim or eltrombopag with at least two months of follow-up for each period.

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
Study Population

Patients with primary Immune Thrombopenia receiving romiplostim and eltrombopag alternatively.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Henri Mondor University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014