French Adult primary Immune Thrombocytopenia: a pHarmacoepidemiological study (FAITH)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28050
• EU PAS number:
  EUPAS4574
• Study ID:
  28050
• Official title and acronym:
  French Adult primary Immune Thrombocytopenia: a pHarmacoepidemiological study (FAITH)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  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. We 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University Toulouse III

France

INSERM 1027

Study timelines

Date when funding contract was signed

Planned: 15/10/2013

Actual: 15/10/2013

Study start date

Planned: 15/10/2013

Actual: 15/10/2013

Data analysis start date

Planned: 15/10/2013

Actual: 15/10/2013

Date of interim report, if expected

Planned: 01/05/2015

Actual: 10/10/2014

Date of final study report

Planned: 01/05/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

University of Toulouse

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable