French Adult Primary Immune Thrombocytopenia (FAITH)

September 30, 2020 updated by: University Hospital, Toulouse

French Adult Primary Immune Thrombocytopenia: a pHarmacoepidemiological Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population of patient registred in national administrative french database

Description

Inclusion Criteria:

  • Incident case of immune thrombocytopenia or control patient

Exclusion Criteria:

  • Patient not registered in the database between 2009 and 2012

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exposition or non exposition to available immune thrombocytopenia persistent
Time Frame: up to 10 years
Data will be extracted until the end of study
up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Each year until 10 years
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
Each year until 10 years
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
Each year until 10 years
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
Each year until 10 years
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
Each year until 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Study Director: Maryse LAPEYRE-MESTRE, PHD, University Hospital of Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31-14-7439B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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