ThrombocytopeniaFAITHNCT03429660
French Adult Primary Immune Thrombocytopenia
An observational study of Thrombocytopenia, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Medical information
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population of patient registred in national administrative french database
Who may be able to join
- Incident case of immune thrombocytopenia or control patient
Who cannot join
- Patient not registered in the database between 2009 and 2012
Trial locations and contacts
1 site in 1 country.
Maryse LAPEYRE-MESTRE, PHD contact
France1 site, 1 recruiting
- Recruiting
University Hospital of Toulouse
Toulouse, 31059
Guillaume MOULIS, PHD, guillaume.moulis@univ-tlse3.fr
About this study
Official title: 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.
- Conditions
- Thrombocytopenia
- Being tested
- Medical information
- Keywords
- Disease epidemiology, Risk assessment, Drug utilisation study, Effectiveness evaluation
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical informationOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Data to be collected are :
- Medical information on Immune Thrombocytopenia treatment Receives: Other: Medical information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposition or non exposition to available immune thrombocytopenia persistent
Data will be extracted until the end of study
Measured: up to 10 years
Secondary outcomes (5)
Mortality as assessed date of death collected in the database
Data will be extracted every year of the study until the end of study
Measured: Each year until 10 years
Number of hospitalization for bleeding in the database
Number of hospitalization for bleeding will be extract from database every year
Measured: Each year until 10 years
Safety of treatment for infections
Number of infections is represented by number of hospitalization and antibiotics dispensation and will be extract from database every year
Measured: Each year until 10 years
Safety of treatment for cardio-vascular events
Number of hospitalization for cardio-vascular events will be extract from database every year
Measured: Each year until 10 years
Safety of treatment for thrombo-embolic events
Number of hospitalization for thrombo-embolic events will be extract from database every year
Measured: Each year until 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study startOct 2013
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryse LAPEYRE-MESTRE, PHD, Study director, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429660
- Sponsor's protocol ID
- RC31-14-7439B
- Acronym
- FAITH
- Status last verified
- Sep 2020
- First submitted
- 21 Feb 2017
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Adult Primary Immune Thrombocytopenia: a pHarmacoepidemiological Study
- ClinicalTrials.gov ID
- NCT03429660
- Acronym / sponsor ID
- FAITH / RC31-14-7439B
- Conditions
- Thrombocytopenia
- Keywords
- Disease epidemiology, Risk assessment, Drug utilisation study, Effectiveness evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: Medical informationData to be collected are : - Medical information on Immune Thrombocytopenia treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of patient registred in national administrative french database
Key inclusion criteria (1 listed)
- Incident case of immune thrombocytopenia or control patient
Key exclusion criteria (1 listed)
- Patient not registered in the database between 2009 and 2012
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical informationThe 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) | Other | Cohort |
Primary outcome
Exposition or non exposition to available immune thrombocytopenia persistent
Time frame: up to 10 years
Data will be extracted until the end of study
5 secondary outcomes
Mortality as assessed date of death collected in the database
Time frame: Each year until 10 years
Number of hospitalization for bleeding in the database
Time frame: Each year until 10 years
Safety of treatment for infections
Time frame: Each year until 10 years
Safety of treatment for cardio-vascular events
Time frame: Each year until 10 years
Safety of treatment for thrombo-embolic events
Time frame: Each year until 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryse LAPEYRE-MESTRE, PHD contact
Maryse LAPEYRE-MESTRE, PHD study director
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maryse LAPEYRE-MESTRE, PHD (maryse.lapeyre-mestre@univ-tlse3.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposition or non exposition to available immune thrombocytopenia persistent (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.