Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:44 PM
Study NCT ID:
NCT00794703
Status:
COMPLETED
Last Update Posted:
2016-03-28
First Post:
2008-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016469', 'term': 'Fungemia'}, {'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077551', 'term': 'Micafungin'}, {'id': 'D017964', 'term': 'Itraconazole'}], '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'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-25', 'studyFirstSubmitDate': '2008-11-19', 'studyFirstSubmitQcDate': '2008-11-19', 'lastUpdatePostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment success rate (fungal breakthrough rate)', 'timeFrame': 'At the end of the study'}], 'secondaryOutcomes': [{'measure': 'Incidence of proven or probable invasive fungal infection', 'timeFrame': 'Throughout the study period'}, {'measure': 'The usage rate of systemic antifungal agents', 'timeFrame': 'During 4 weeks after the administration'}, {'measure': 'Time to treatment failure', 'timeFrame': 'During the study period'}, {'measure': 'Assessment of Adverse events, Laboratory examinations and vital signs evaluation', 'timeFrame': 'Throughout the study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antifungal', 'micafungin', 'itraconazole'], 'conditions': ['Fungemia', 'Fungal Infections']}, 'referencesModule': {'references': [{'pmid': '22469884', 'type': 'DERIVED', 'citation': 'Huang X, Chen H, Han M, Zou P, Wu D, Lai Y, Huang H, Chen X, Liu T, Zhu H, Wang J, Hu J. Multicenter, randomized, open-label study comparing the efficacy and safety of micafungin versus itraconazole for prophylaxis of invasive fungal infections in patients undergoing hematopoietic stem cell transplant. Biol Blood Marrow Transplant. 2012 Oct;18(10):1509-16. doi: 10.1016/j.bbmt.2012.03.014. Epub 2012 Mar 30.'}], 'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=MCFGCN02-0', 'label': 'Link to results on Astellas Clinical Study Results Web site'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients', 'detailedDescription': 'Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:\n\n * Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant\n * Any patient undergoing an allogeneic hematopoietic stem cell transplant\n\nExclusion Criteria:\n\n* Patients with moderate or severe liver disease, as defined by:\n\n * AST or ALT greater than 5 times upper limit of normal (ULN), OR;\n * Total bilirubin greater than 2.5 times ULN\n* Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment'}, 'identificationModule': {'nctId': 'NCT00794703', 'briefTitle': 'A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant', 'orgStudyIdInfo': {'id': 'MCFGCN02-0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1. Micafungin', 'interventionNames': ['Drug: micafungin (Mycamine)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Itraconazole', 'interventionNames': ['Drug: itraconazole']}], 'interventions': [{'name': 'micafungin (Mycamine)', 'type': 'DRUG', 'otherNames': ['Mycamine', 'FK463'], 'description': 'Intravenous', 'armGroupLabels': ['1. Micafungin']}, {'name': 'itraconazole', 'type': 'DRUG', 'otherNames': ['Sporanox'], 'description': 'oral', 'armGroupLabels': ['2. Itraconazole']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Jiangsu', 'country': 'China'}, {'city': 'Nanning', 'country': 'China', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'country': 'China', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': "Xi'an", 'country': 'China', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}