Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-28 @ 4:06 PM
Study NCT ID:
NCT00036166
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2002-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of FK463 for the Treatment of Invasive Aspergillosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001228', 'term': 'Aspergillosis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077551', 'term': 'Micafungin'}], 'ancestors': [{'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2002-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2002-05-08', 'studyFirstSubmitQcDate': '2002-05-08', 'lastUpdatePostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2002-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-01-31', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Aspergillus', 'Anti-Fungal'], 'conditions': ['Aspergillosis']}, 'referencesModule': {'references': [{'pmid': '16678903', 'type': 'RESULT', 'citation': 'Denning DW, Marr KA, Lau WM, Facklam DP, Ratanatharathorn V, Becker C, Ullmann AJ, Seibel NL, Flynn PM, van Burik JA, Buell DN, Patterson TF. Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis. J Infect. 2006 Nov;53(5):337-49. doi: 10.1016/j.jinf.2006.03.003. Epub 2006 May 6.'}, {'pmid': '18983417', 'type': 'RESULT', 'citation': 'Kontoyiannis DP, Ratanatharathorn V, Young JA, Raymond J, Laverdiere M, Denning DW, Patterson TF, Facklam D, Kovanda L, Arnold L, Lau W, Buell D, Marr KA. Micafungin alone or in combination with other systemic antifungal therapies in hematopoietic stem cell transplant recipients with invasive aspergillosis. Transpl Infect Dis. 2009 Feb;11(1):89-93. doi: 10.1111/j.1399-3062.2008.00349.x. Epub 2008 Oct 8.'}], 'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/study.aspx?ID=59', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.', 'detailedDescription': 'This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Has proven or probable systemic infection with Aspergillus species\n\nExclusion Criteria\n\n* Has abnormal liver test parameters, e.g., AST or ALT \\> 10 times upper limit of normal\n* Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external otitis but does not have histologic evidence of tissue invasion\n* Has life-expectancy judged to be less than 5 days'}, 'identificationModule': {'nctId': 'NCT00036166', 'briefTitle': 'Study of FK463 for the Treatment of Invasive Aspergillosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis', 'orgStudyIdInfo': {'id': 'FG463-21-01'}, 'secondaryIdInfos': [{'id': '98-0-046', 'type': 'OTHER', 'domain': 'Alternate Protocol Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'FK463', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinische Univ.-Klinik', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'A-4010', 'city': 'Linz', 'country': 'Austria', 'facility': 'Krankenhaus Elisabethinen Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': "Hopital Henri Mondor, Service d'Hematologie Clinique", 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': "Hotel Dieu, Service d'Hematologie", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '10', 'city': 'Paris', 'country': 'France', 'facility': "Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': "Hopital Necker Enfants Malades, Service d'Hematologie", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'D-60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Johann Wolfgang Goethe Universitat, Medizinische Klinik III', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'D-67655', 'city': 'Kaiserslautern', 'country': 'Germany', 'facility': 'Westpfalz Krankehaus', 'geoPoint': {'lat': 49.443, 'lon': 7.77161}}, {'zip': 'D-04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': 'D-67063', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Klinikum der Stadt, Medizinische Klinik A', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '55101', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Uniklinik Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': 'D-81366', 'city': 'München', 'country': 'Germany', 'facility': 'LMU Munchen, Hamatopoetische Zell - Transplantation', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': 'E-97070', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': 'I 16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Nationale Institute for Cancer Research', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00-957', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Institute of Haematology and Blood Transfusion', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': 'ES 28041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic I provencial, Servicio Enfermadades Infecciosas', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'ES 28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'ES 28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'SE141 86', 'city': 'Huddinge', 'country': 'Sweden', 'facility': 'Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital, Dept. of Haematological Oncology', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Christie Hospital NHS Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'SM2 5PT', 'city': 'Sutton Surrey', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}