Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-01-07 @ 6:53 AM
Study NCT ID:
NCT07000695
Status:
AVAILABLE
Last Update Posted:
2025-06-03
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managed Access Programs for TQJ230, Pelacarsen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730804', 'term': 'pelacarsen'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}, 'nPtrsToThisExpAccNctId': 4}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['MAP', 'Manage Access Program', 'TQJ230', 'Pelacarsen', 'Atherosclerotic Cardiovascular Disease', 'ASCVD'], 'conditions': ['Atherosclerotic Cardiovascular Disease, ASCVD']}, 'descriptionModule': {'briefSummary': 'The purpose of this registration is to list Managed Access Programs (MAPs) related to TQJ230, pelacarsen', 'detailedDescription': 'CTQJ230A12013M - Available - Managed Access Program (MAP) Cohort Treatment Plan (CTQJ230A12013M) to provide access to pelacarsen (TQJ230) for (Atherosclerotic Cardiovascular Disease, ASCVD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. An independent request was received from a licensed physician.\n2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.\n3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.\n4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).\n6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.\n7. Managed Access provision is allowed per local laws/regulations.'}, 'identificationModule': {'nctId': 'NCT07000695', 'briefTitle': 'Managed Access Programs for TQJ230, Pelacarsen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Managed Access Programs for TQJ230, Pelacarsen', 'orgStudyIdInfo': {'id': 'CTQJ230A12013M'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pelacarsen', 'type': 'DRUG', 'otherNames': ['TQJ230'], 'description': 'Patients receive Pelacarsen'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '+41613241111'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}