Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT04221412
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-08-29
First Post:
2020-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pre-Approval Access to JNJ-53718678 for the Treatment of Respiratory Syncytial Virus (RSV) Infection in (a) Immunocompromised Adult and Pediatric Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary', 'Italy', 'Spain', 'Sweden', 'United Kingdom']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624632', 'term': 'JNJ-53718678'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 3}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-07', 'lastUpdatePostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Virus']}, 'descriptionModule': {'briefSummary': 'The purpose of this pre-approval access program is to provide treatment to immunocompromised participants with serious/life-threatening diseases or conditions (Respiratory Syncytial Virus \\[RSV\\] infection) and to collect the safety data to understand the safety profile of JNJ-53718678.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT']}, 'identificationModule': {'nctId': 'NCT04221412', 'briefTitle': 'Pre-Approval Access to JNJ-53718678 for the Treatment of Respiratory Syncytial Virus (RSV) Infection in (a) Immunocompromised Adult and Pediatric Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Sciences Ireland UC'}, 'officialTitle': 'JNJ-53718678 RSV Pre-Approval Access_Single Patient Access (SPR) for Patients Diagnosed With RSV', 'orgStudyIdInfo': {'id': 'CR108653'}, 'secondaryIdInfos': [{'id': '53718678RSV4001', 'type': 'OTHER', 'domain': 'Janssen Sciences Ireland UC'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'JNJ-53718678', 'type': 'DRUG', 'description': 'JNJ-53718678 will be administered as directed by treating physician.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Sciences Ireland UC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}