French Adult Primary Immune Thrombocytopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Thrombocytopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

Data to be collected are :

\- Medical information on Immune Thrombocytopenia treatment

Medical information

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER