Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-29 @ 12:48 PM
Study NCT ID:
NCT01206504
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-02-22
First Post:
2010-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014901', 'term': 'West Nile Fever'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'C000629404', 'term': 'acute flaccid myelitis'}], 'ancestors': [{'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2010-09-17', 'studyFirstSubmitQcDate': '2010-09-21', 'lastUpdatePostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['West Nile virus', 'WNV', 'Encephalitis', 'Meningitis', 'Acute Flaccid Paralysis', 'Monoclonal Antibody', 'WNND', 'West Nile Neuroinvasive Disease', 'Accidental Exposure to West Nile Virus'], 'conditions': ['West Nile Virus Infection']}, 'descriptionModule': {'briefSummary': 'This study will test an experimental drug called MGAWN1 for the treatment of West Nile infections.', 'detailedDescription': 'The objective of this study is to provide expanded access to MGAWN1; the study is not intended for subjects who are eligible for and have access to non-expanded access protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. For West Nile Neuroinvasive Disease subjects: Have neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis\n2. For immunocompromised subjects with suspected West Nile virus infection:\n\n * Receiving immunosuppressive treatment for any disease, such as autoimmune diseases, or transplant recipients; or\n * Have received organs or tissues or cells from donors likely infected with West Nile virus (as shown by serology or PCR/NAT from the donor, organs, or tissues) or\n * Have acquired immunodeficiency (other than from immunosuppressive treatment or from receiving infected transplants) or congenital immunodeficiency\n3. For subjects with substantial exposure to West Nile virus: Exposure by any route, including percutaneous, inhalation, or mucosal exposure (such as might occur in a laboratory accident)\n4. Develop signs and/or symptoms within 14 days before study enrollment'}, 'identificationModule': {'nctId': 'NCT01206504', 'briefTitle': 'Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure', 'organization': {'class': 'INDUSTRY', 'fullName': 'MacroGenics'}, 'officialTitle': 'Expanded Access to MGAWN1 in Subjects With: Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection and a Compromised Immune System; or Substantial Accidental Exposure to West Nile Virus', 'orgStudyIdInfo': {'id': 'CP-MGAWN1-EA1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MGAWN1', 'type': 'BIOLOGICAL', 'description': 'Humanized monoclonal to West Nile virus. Dose=30mg/kg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MacroGenics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}