NCT03429660

French Adult Primary Immune Thrombocytopenia

French Adult Primary Immune Thrombocytopenia: a pHarmacoepidemiological Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
OTHER	Medical information	The information collected are about : * Introduction or non-introduction of treatment * Cumulative dose of treatment * Drug dispensation and withdrawal * Hospitalization reason * Safety information * Demographic data (date of death)

Timeline

• Start date: 2013-10-01
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2018-02-12
• Last updated: 2020-10-01

Locations

1 site across 1 country: France