Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-02 @ 4:41 AM
Study NCT ID:
NCT06439966
Status:
AVAILABLE
Last Update Posted:
2025-04-04
First Post:
2024-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to ABBV-787
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Expanded Access', 'Pre-approval Access', 'Compassionate Use', 'Special Access Program', 'Named Patient Basis', 'Special Access Scheme'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=C25-244', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-787 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- The participant must not be eligible for an ABBV-787 clinical trial.'}, 'identificationModule': {'nctId': 'NCT06439966', 'briefTitle': 'Expanded Access to ABBV-787', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Expanded Access to ABBV-787', 'orgStudyIdInfo': {'id': 'C25-244'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ABBV-787', 'type': 'DRUG', 'description': 'Intravenous (IV) Infusion'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}