Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT00652067
Status:
COMPLETED
Last Update Posted:
2008-04-03
First Post:
2008-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015270', 'term': 'Mycobacterium avium-intracellulare Infection'}], 'ancestors': [{'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-02', 'studyFirstSubmitDate': '2008-03-31', 'studyFirstSubmitQcDate': '2008-04-02', 'lastUpdatePostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mycobacterium avium-intracellulare'], 'conditions': ['Infection, Mycobacterium Avium-Intracellulare']}, 'descriptionModule': {'briefSummary': 'This protocol is an single patient IND to provide clofazamine to treat one patient who has MAI and is resistant to or can not tolerate standard of care. The drug is not otherwise available.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Single patient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment of one patient with MAI\n\nExclusion Criteria:\n\n* No other patients will be treated'}, 'identificationModule': {'nctId': 'NCT00652067', 'briefTitle': 'Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'IND for One Patient to Receive Clofazamine for Treatment of MAI', 'orgStudyIdInfo': {'id': '0604001371'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Only one patient is being treated under a single patient IND.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Margaret Pisani, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Margaret Pisani, MD', 'oldOrganization': 'Yale University School of Medicine'}}}}