We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

French Adult Primary Immune Thrombocytopenia (FAITH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03429660
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Thrombocytopenia Other: Medical information

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: French Adult Primary Immune Thrombocytopenia: a pHarmacoepidemiological Study
Study Start Date : October 2013
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Cohort

Data to be collected are :

- Medical information on Immune Thrombocytopenia treatment

 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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Exposition or non exposition to available immune thrombocytopenia persistent [ Time Frame: up to 10 years ]
    Data will be extracted until the end of study


Secondary Outcome Measures :
  1. Mortality as assessed date of death collected in the database [ Time Frame: Each year until 10 years ]
    Data will be extracted every year of the study until the end of study

  2. Number of hospitalization for bleeding in the database [ Time Frame: Each year until 10 years ]
    Number of hospitalization for bleeding will be extract from database every year

  3. Safety of treatment for infections [ Time Frame: Each year until 10 years ]
    Number of infections is represented by number of hospitalization and antibiotics dispensation and will be extract from database every year

  4. Safety of treatment for cardio-vascular events [ Time Frame: Each year until 10 years ]
    Number of hospitalization for cardio-vascular events will be extract from database every year

  5. Safety of treatment for thrombo-embolic events [ Time Frame: Each year until 10 years ]
    Number of hospitalization for thrombo-embolic events will be extract from database every year


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population of patient registred in national administrative french database
Criteria

Inclusion Criteria:

  • Incident case of immune thrombocytopenia or control patient

Exclusion Criteria:

  • Patient not registered in the database between 2009 and 2012
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429660


Contacts
Layout table for location contacts
Contact: Maryse LAPEYRE-MESTRE, PHD maryse.lapeyre-mestre@univ-tlse3.fr

Locations
Layout table for location information
France
University Hospital of Toulouse Recruiting
Toulouse, France, 31059
Contact: Guillaume MOULIS, PHD       guillaume.moulis@univ-tlse3.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Study Director: Maryse LAPEYRE-MESTRE, PHD University Hospital of Toulouse
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03429660    
Other Study ID Numbers: RC31-14-7439B
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Toulouse:
Disease epidemiology
Risk assessment
Drug utilisation study
Effectiveness evaluation
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombocytopenia
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
 Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations