Status: Ongoing First registered on: 23/08/2013
Last updated on: 13/02/2019
1. Study identification
EU PAS Register NumberEUPAS4574
Official titleFrench Adult primary Immune Thrombocytopenia: a pHarmacoepidemiological study
Study title acronymFAITH
Study typeObservational study
Brief description of the studyPrimary 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacoepidemiology INSERM 1027
Department/Research groupPharmacoepidemiology research team
Organisation/affiliationUniversity of Toulouse 3 and INSERM 1027
Website/Homepagehttp://www.u1027.inserm.fr/
Details of (Primary) lead investigator
Title Dr
Last name Lapeyre-Mestre
First name Maryse
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/10/201315/10/2013
Start date of data collection15/10/201315/10/2013
Start date of data analysis15/10/201315/10/2013
Date of interim report, if expected01/05/201510/10/2014
Date of final study report01/05/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councilsUniversity of Toulouse100
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Moulis
First name Guillaume
Address line 1UMR1027, team 6
Address line 2Faculté de Médecine 
Address line 337 allées Jules Guesde 
CityToulouse 
Postcode31000 
CountryFrance
Phone number (incl. country code)33561145606 
Alternative phone number 
Fax number (incl. country code)33561145928 
Email address guillaume.moulis@univ-tlse3.fr
Public Enquiries
Title Dr 
Last name Moulis 
First name Guillaume 
Address line 1UMR1027, team 6 
Address line 2Faculté de Médecine 
Address line 337 allées Jules Guesde 
CityToulouse 
Postcode31000 
CountryFrance 
Phone number (incl. country code)33561145606 
Alternative phone number 
Fax number (incl. country code)33561145928 
Email address guillaume.moulis@univ-tlse3.fr 
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