French Adult Primary Immune Thrombocytopenia

• Conditions: Thrombocytopenia
• Interventions: Other: Medical information

• Registration Number: NCT03429660
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-01
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Incident case of immune thrombocytopenia or control patient

Exclusion Criteria

• Patient not registered in the database between 2009 and 2012

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Medical information	Data to be collected are : - Medical information on Immune Thrombocytopenia treatment

Primary Outcome Measures

Name	Time	Method
Exposition or non exposition to available immune thrombocytopenia persistent	up to 10 years	Data will be extracted until the end of study

Secondary Outcome Measures

Name	Time	Method
Mortality as assessed date of death collected in the database	Each year until 10 years	Data will be extracted every year of the study until the end of study
Number of hospitalization for bleeding in the database	Each year until 10 years	Number of hospitalization for bleeding will be extract from database every year
Safety of treatment for cardio-vascular events	Each year until 10 years	Number of hospitalization for cardio-vascular events will be extract from database every year
Safety of treatment for thrombo-embolic events	Each year until 10 years	Number of hospitalization for thrombo-embolic events will be extract from database every year
Safety of treatment for infections	Each year until 10 years	Number of infections is represented by number of hospitalization and antibiotics dispensation and will be extract from database every year

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France