French Adult Primary Immune Thrombocytopenia

NCT03429660 | Unknown

• 1 other identifier: RC31-14-7439B
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombocytopenia

Keywords

Disease epidemiology; Risk assessment; Drug utilisation study; Effectiveness evaluation

Outcome Measures

Primary Outcomes (1)

• Exposition or non exposition to available immune thrombocytopenia persistent

  Data will be extracted until the end of study

  up to 10 years

Secondary Outcomes (5)

• Mortality as assessed date of death collected in the database

  Each year until 10 years

• Number of hospitalization for bleeding in the database

  Each year until 10 years

• Safety of treatment for infections

  Each year until 10 years

• Safety of treatment for cardio-vascular events

  Each year until 10 years

• Safety of treatment for thrombo-embolic events

  Each year until 10 years

Study Arms (1)

Cohort

Data to be collected are : \- Medical information on Immune Thrombocytopenia treatment

Other: Medical information

Interventions

Medical information 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)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population of patient registred in national administrative french database

You may qualify if:

• Incident case of immune thrombocytopenia or control patient

You may not qualify if:

• Patient not registered in the database between 2009 and 2012

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Maryse LAPEYRE-MESTRE, PHD

  University Hospital of Toulouse

  STUDY DIRECTOR

Central Study Contacts

Maryse LAPEYRE-MESTRE, PHD

CONTACT

maryse.lapeyre-mestre@univ-tlse3.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 12, 2018
• Study Start: October 1, 2013
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 1, 2020

Record last verified: 2020-09

Locations

FR (1)