French Adult Primary Immune Thrombocytopenia

Thrombocytopenia Clinical Trial

— FAITH  

Official title:

French Adult Primary Immune Thrombocytopenia: a pHarmacoepidemiological Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03429660
• Other study ID #: RC31-14-7439B
• Status: Recruiting
• Start date: October 2013
• Est. completion date: May 2023

Study information

• Verified date: September 2020
• Source: University Hospital, Toulouse
• Contact: Maryse LAPEYRE-MESTRE, PHD
• Email: maryse.lapeyre-mestre[@]univ-tlse3.fr
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Incident case of immune thrombocytopenia or control patient

Exclusion Criteria:

• Patient not registered in the database between 2009 and 2012

Related Conditions & MeSH terms

• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

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)

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposition or non exposition to available immune thrombocytopenia persistent	Data will be extracted until the end of study	up to 10 years
Secondary	Mortality as assessed date of death collected in the database	Data will be extracted every year of the study until the end of study	Each year until 10 years
Secondary	Number of hospitalization for bleeding in the database	Number of hospitalization for bleeding will be extract from database every year	Each year until 10 years
Secondary	Safety of treatment for infections	Number of infections is represented by number of hospitalization and antibiotics dispensation and will be extract from database every year	Each year until 10 years
Secondary	Safety of treatment for cardio-vascular events	Number of hospitalization for cardio-vascular events will be extract from database every year	Each year until 10 years
Secondary	Safety of treatment for thrombo-embolic events	Number of hospitalization for thrombo-embolic events will be extract from database every year	Each year until 10 years