Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-27 @ 7:06 PM
Study NCT ID:
NCT03395769
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-05-29
First Post:
2017-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Patient Expanded Access for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'lastUpdateSubmitDate': '2019-05-24', 'studyFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}}, 'descriptionModule': {'briefSummary': 'The purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, AB-SA01, for patients with serious or immediately life-threatening Staphylococcus aureus infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under FDA\'s Expanded Access regulations and criteria set forth by AmpliPhi Biosciences Corporation.\n\nTo be considered for expanded access, the request should be submitted to AmpliPhi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. Treating physicians should contact AmpliPhi by emailing expandedaccess@ampliphibio.com with "Expanded Access Request" in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition.\n\nAny approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03395769', 'briefTitle': 'Individual Patient Expanded Access for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic', 'organization': {'class': 'INDUSTRY', 'fullName': 'Armata Pharmaceuticals, Inc.'}, 'officialTitle': 'Expanded Access Program for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic, for the Treatment of Serious Infections Caused by Staphylococcus Aureus.', 'orgStudyIdInfo': {'id': 'AB-SA01-EAP01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AB-SA01', 'type': 'BIOLOGICAL', 'description': 'AB-SA01 is an investigational bacteriophage therapeutic for treatment of Staphylococcus aureus infections'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armata Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}