French Adult Primary Immune Thrombocytopenia (FAITH)

Toulouse University Hospital

Status: Unknown

Conditions: Thrombocytopenia

Treatments: Other: Medical information

Study type: Observational

Funder types: Other

Identifiers

NCT03429660

RC31-14-7439B

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Incident case of immune thrombocytopenia or control patient

Exclusion criteria

• Patient not registered in the database between 2009 and 2012

Trial design

10,000 participants in 1 patient group

Cohort

Description:

Data to be collected are : - Medical information on Immune Thrombocytopenia treatment

Treatment:

Other: Medical information