Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT01148160
Status:
TERMINATED
Last Update Posted:
2014-04-10
First Post:
2010-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic Malignancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D055744', 'term': 'Invasive Pulmonary Aspergillosis'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D055732', 'term': 'Pulmonary Aspergillosis'}, {'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065819', 'term': 'Voriconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Venous blood sampling will be carried out at steady state for therapeutic drug monitoring(trough sampling:right before the dose)\n* Genotyping will be performed using peripheral blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-09', 'studyFirstSubmitDate': '2010-06-18', 'studyFirstSubmitQcDate': '2010-06-21', 'lastUpdatePostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful outcome at 12 weeks after voriconazole use', 'timeFrame': '12 weeks', 'description': 'Successful outcome = complete response + partial response Unsuccessful outcome = stable disease + failure of therapy + indeterminate response'}], 'secondaryOutcomes': [{'measure': 'IFI (invasive fungal infection)-related mortality at 12 weeks', 'timeFrame': '12 weeks', 'description': 'IFI (invasive fungal infection)-related mortality at 12 weeks'}, {'measure': 'Successful outcomes at various time points', 'timeFrame': '1 week, 2 weeks, 4 weeks, and 8 weeks', 'description': 'Successful outcomes at 1 week,2 weeks,4 weeks, and 8 weeks after voriconazole use'}, {'measure': 'Non-IFI (invasive fungal infection)-related mortality at 12 weeks', 'timeFrame': '12 weeks', 'description': 'Non-IFI (invasive fungal infection)-related mortality at 12 weeks'}, {'measure': 'breakthrough IFI', 'timeFrame': '12 weeks', 'description': 'breakthrough IFI'}, {'measure': 'Adverse drug reactions', 'timeFrame': '12 weeks', 'description': 'Adverse drug reactions (liver function test impairment, visual disturbance, hallucination, photosensitive rash, renal impairment)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['voriconazole', 'invasive pulmonary aspergillosis', 'hematologic malignancy', 'therapeutic drug monitoring', 'genetic polymorphism', 'efficacy', 'safety'], 'conditions': ['Invasive Fungal Infection']}, 'descriptionModule': {'briefSummary': 'Multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes.\n\nVoriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by CYP2C19. The polymorphisms account for a relatively large portion of inter-individual variance observed in voriconazole plasma concentrations.\n\nHowever, there are limited data on the relationships between voriconazole blood levels and clinical outcomes or safety in Asian populations.\n\nThe purpose of this study is to investigate the relationships of voriconazole blood levels with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with invasive pulmonary aspergillosis.', 'detailedDescription': 'The investigators are trying to establish that routine clinical practice for voriconazole therapeutic drug monitoring can improve the efficacy and safety outcomes.\n\nIn Korean patients with hematologic malignancy, the investigators also want to propose the optimal dosing guideline of voriconazole with different genetic polymorphisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: all items below\n\n* male or female ≥ 15 years of age\n* immunocompromised patients with hematologic disorders\n* patients received voriconazole due to treat proven, probable invasive (pulmonary) aspergillosis\n\nExclusion Criteria:\n\n* severe hepatic dysfunction (t.bil, AST, ALT, ALP \\> 5 x upper normal limit)\n* who experienced hypersensitivity to azoles\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT01148160', 'briefTitle': 'Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic Malignancy', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'The Correlation of Voriconazole Trough Plasma Levels With Genetic Polymorphism, Efficacy, and Safety Outcomes in Hematologic Malignancy Patients With Invasive Pulmonary Aspergillosis', 'orgStudyIdInfo': {'id': 'VCZ-IPA-HEM-2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea', 'interventionNames': ['Drug: voriconazole']}], 'interventions': [{'name': 'voriconazole', 'type': 'DRUG', 'description': 'intravenous, oral administration', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center, University of Ulsan College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistantant Professor', 'investigatorFullName': 'Sung-Han Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}