Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 4:38 PM
Study NCT ID:
NCT03429660
Status:
UNKNOWN
Last Update Posted:
2020-10-01
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Adult Primary Immune Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exposition or non exposition to available immune thrombocytopenia persistent', 'timeFrame': 'up to 10 years', 'description': 'Data will be extracted until the end of study'}], 'secondaryOutcomes': [{'measure': 'Mortality as assessed date of death collected in the database', 'timeFrame': 'Each year until 10 years', 'description': 'Data will be extracted every year of the study until the end of study'}, {'measure': 'Number of hospitalization for bleeding in the database', 'timeFrame': 'Each year until 10 years', 'description': 'Number of hospitalization for bleeding will be extract from database every year'}, {'measure': 'Safety of treatment for infections', 'timeFrame': 'Each year until 10 years', 'description': 'Number of infections is represented by number of hospitalization and antibiotics dispensation and will be extract from database every year'}, {'measure': 'Safety of treatment for cardio-vascular events', 'timeFrame': 'Each year until 10 years', 'description': 'Number of hospitalization for cardio-vascular events will be extract from database every year'}, {'measure': 'Safety of treatment for thrombo-embolic events', 'timeFrame': 'Each year until 10 years', 'description': 'Number of hospitalization for thrombo-embolic events will be extract from database every year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Disease epidemiology', 'Risk assessment', 'Drug utilisation study', 'Effectiveness evaluation'], 'conditions': ['Thrombocytopenia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population of patient registred in national administrative french database', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Incident case of immune thrombocytopenia or control patient\n\nExclusion Criteria:\n\n* Patient not registered in the database between 2009 and 2012'}, 'identificationModule': {'nctId': 'NCT03429660', 'acronym': 'FAITH', 'briefTitle': 'French Adult Primary Immune Thrombocytopenia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'French Adult Primary Immune Thrombocytopenia: a pHarmacoepidemiological Study', 'orgStudyIdInfo': {'id': 'RC31-14-7439B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort', 'description': 'Data to be collected are :\n\n\\- Medical information on Immune Thrombocytopenia treatment', 'interventionNames': ['Other: Medical information']}], 'interventions': [{'name': 'Medical information', 'type': 'OTHER', 'description': 'The information collected are about :\n\n* Introduction or non-introduction of treatment\n* Cumulative dose of treatment\n* Drug dispensation and withdrawal\n* Hospitalization reason\n* Safety information\n* Demographic data (date of death)', 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume MOULIS, PHD', 'role': 'CONTACT', 'email': 'guillaume.moulis@univ-tlse3.fr'}], 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Maryse LAPEYRE-MESTRE, PHD', 'role': 'CONTACT', 'email': 'maryse.lapeyre-mestre@univ-tlse3.fr'}], 'overallOfficials': [{'name': 'Maryse LAPEYRE-MESTRE, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}