Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-03-05 @ 6:09 PM
Study NCT ID:
NCT06485635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-life-persistence to Antifibrotic Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530716', 'term': 'nintedanib'}, {'id': 'C093844', 'term': 'pirfenidone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10646}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation)', 'timeFrame': 'up to 30 months'}], 'secondaryOutcomes': [{'measure': 'AF prevalence in French population', 'timeFrame': 'up to 5 years'}, {'measure': 'AF incidence in French population', 'timeFrame': 'up to 4 years'}, {'measure': 'Number of AF treated patients split by indication', 'timeFrame': 'up to 2 years', 'description': 'Indications:\n\n* Idiopathic Pulmonary Fibrosis (IPF)\n* Interstitial Lung Disease associated with Systemic Sclerosis (SSc-ILD)\n* Progressive Pulmonary Fibrosis (PPF)'}, {'measure': 'Number of patients adherent to AF treatment', 'timeFrame': 'up to 30 months', 'description': 'In incident AF patients, percentage of days covered (PDC) will be calculated at different time point to measure the adherence to AF treatment for patients persistent to treatment at this time point.\n\nThe PDC is the ratio dividing the number of days exposed by the number of days in the period evaluated.\n\nA PDC≥ 80% is considered as a good adherence to medication.'}, {'measure': 'Percentage of the target cumulative dose of treatment received by the patients', 'timeFrame': 'up to 30 months'}, {'measure': 'Influence of factors (yes/no) associated with persistence to AF treatments', 'timeFrame': 'up to 30 months', 'description': 'For a pre-determined list of variables (as defined in the study protocol) in incident AF patients, a multivariate time-dependant Cox model will test several covariates to check if they are associated with persistence to AF treatment.'}, {'measure': 'Number of patients with switch from one AF treatment to the another with no treatment stop', 'timeFrame': 'up to 5 years'}, {'measure': 'Number of patients at site of follow-up (identified as 2 lung function tests performed in the center)', 'timeFrame': 'up to 5 years'}, {'measure': 'Overall Survival (defined as time from index date (first reimbursement of AF treatment) to death from any cause)', 'timeFrame': 'up to5 years'}, {'measure': 'Event-free survival', 'timeFrame': 'up to 5 years', 'description': 'Defined as the time from index date to\n\n* oxygenotherapy onset\n* hospitalisation for respiratory exacerbations\n* hospitalisation for other respiratory diseases\n* ath from any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will help to better understand the persistence rate to antifibrotic (AF) treatment in real life in France and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to AF treatment.\n\nPrimary objective of the study is to measure the percentage of patients still treated up to 30 months after AF treatment initiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAll patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.\n\nExclusion criteria:\n\nNo exclusion criteria will be applied.'}, 'identificationModule': {'nctId': 'NCT06485635', 'acronym': 'REPEAT', 'briefTitle': 'Real-life-persistence to Antifibrotic Treatments', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Real-life-Persistence to Antifibrotic Treatments', 'orgStudyIdInfo': {'id': '1199-0568'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with a reimbursement of AF treatment', 'interventionNames': ['Drug: Nintedanib', 'Drug: Pirfenidone']}], 'interventions': [{'name': 'Nintedanib', 'type': 'DRUG', 'description': 'Nintedanib', 'armGroupLabels': ['Patients with a reimbursement of AF treatment']}, {'name': 'Pirfenidone', 'type': 'DRUG', 'description': 'Pirfenidone', 'armGroupLabels': ['Patients with a reimbursement of AF treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Clinityx', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}