Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 8:35 PM
Study NCT ID:
NCT03843892
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2024-12-10
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530716', 'term': 'nintedanib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 2}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-02-14', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Lung Diseases, Interstitial']}, 'descriptionModule': {'briefSummary': 'This Expanded Access Program is intended to facilitate the availability of OFEV to patients suffering from non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) with a progressive clinical course despite Standard of Care treatment and for whom no satisfactory authorised alternative therapy exists or who cannot enter a clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNone\n\nExclusion Criteria:\n\n\\- Patients who are eligible for and can participate in an ongoing non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) study will be excluded from participation in this Expanded Access Program (EAP).'}, 'identificationModule': {'nctId': 'NCT03843892', 'briefTitle': 'An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Expanded Access Use of OFEV (Nintedanib) in Non-IPF Interstitial Lung Disease', 'orgStudyIdInfo': {'id': '1199-0380'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OFEV', 'type': 'DRUG', 'description': 'twice daily'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Lung Research Center, LLC', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Glacier View Research Institute', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '14559', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '24523', 'city': 'Bedford', 'state': 'Virginia', 'country': 'United States', 'facility': 'Centra Medical Group', 'geoPoint': {'lat': 37.33431, 'lon': -79.52309}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Medical Campus', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}