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 GSK Clinical Study Register is no longer maintained for this study.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
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:
Enrollment:
150
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
- 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 .
Inclusion and exclusion criteria
Inclusion criteria:
- 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 . Cohort non-inclusion criteria: -Patient who has participated or is participating in a clinical trial -Patient having already received prior therapy with TPO receptor agonists
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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