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Clinical Trial Summary

Primary immune thrombocytopenia (ITP) is rare. First-line treatment is corticotherapy. Then, several second-line treatments (SLT) are available: splenectomy, off-label rituximab and thrombopoietin-receptor agonists since 2009. The compared efficacy and safety on clinical events in the long-term are unknown. The main objective of the FAITH study is to build the cohort of all treated adult persistent (≥3 months) primary ITP patients in France, to assess the benefit-to-risk ratio of SLT in real-life practice. Data source is the database of French Health Insurance System (SNIIRAM) which covers the entire French population. It collects demographic, chronic disease, hospitalization and drug dispensing data. All patients with ITP were extracted from 2009 to 2012, and then every year for 10 years. The investigator will build the cohort from raw data. Outcomes (death, hospitalization, drug dispensing) will be compared according to SLT, with controls from the general population and untreated patients.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03429660
Study type Observational
Source University Hospital, Toulouse
Contact Maryse LAPEYRE-MESTRE, PHD
Email maryse.lapeyre-mestre@univ-tlse3.fr
Status Recruiting
Phase
Start date October 2013
Completion date May 2023

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