Last updated: 11/03/2018 18:32:12
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.

OBSERVATIONAL STUDY OF CHRONIC IMMUNE THROMBOCYTOPENIC PURPURA (ITP) TREATED BY THROMBOPOIETIN RECEPTOR AGONISTS (TPO-R) IN FRANCE

GSK study ID
115804
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: OBSERVATIONAL STUDY OF CHRONIC IMMUNE THROMBOCYTOPENIC PURPURA (ITP) TREATED BY THROMBOPOIETIN RECEPTOR AGONISTS (TPO-R) IN FRANCE
Trial description: Immune thrombocytopenia, previously called Immune thrombocytopenic purpura (ITP), is an autoimmune coagulation disorder characterised by isolated thrombocytopenia (platelet count < 150 x 109/L).
The annual incidence in Europe is estimated to be between 2.68 and 3.9 per 100,000 person-years and the prevalence in France is 25/100,000. ITP is classed into three categories according to the duration and course of the disease: 1/ newly diagnosed ITP, of not more than three months in duration, 2/ persistent ITP (3 to 12 months) and 3/ chronic ITP (lasting for more than 12 months).
Medication is only indicated for patients with a platelet count < 30 x 109/L, though the best strategy is still controversial and primary therapy must be individually tailored for each patient. First-line treatments are corticosteroids and intravenous immunoglobulins (IVIg) which only have transient efficacy. Splenectomy represents the reference surgical treatment for Chronic ITP. After splenectomy or when surgery is contraindicated second-line drug therapy may be proposed to patients: corticosteroids in combination with IVIg, Rituximab or TPO receptor agonists.
The purpose of the SATURNE observational study is to obtain epidemiological data about real-life use of TPO receptor agonists and their place in the management of adult patients with chronic ITP.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

 Describe the profile of adult chronic ITP patients treated by TPO receptor agonists and the clinical course of their disease over a 2-year period.

Timeframe: M0, M6, M12 and M24

Secondary outcomes:

 Assess the quality of life and satisfaction of adult patients with Chronic ITP treated by TPO receptor agonists and changes in these treatment outcomes during follow-up.

Timeframe: M0, M6, M12 and M24

Interventions:
  • Drug: eltrombopag
  • Enrollment:
    150
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Purpura, Thrombocytopaenic, Idiopathic
    Product
    eltrombopag
    Collaborators
    Not applicable
    Study date(s)
    April 2012 to March 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Cohort inclusion criteria:
    • Patient from the observatory and initiating, within the five last weeks or during the inclusion period, treatment by TPO receptor agonists within the MA framework .

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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