Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-28 @ 4:07 AM
Study NCT ID:
NCT01968395
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2013-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077336', 'term': 'Caspofungin'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2014-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2013-09-25', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of serum caspofungine concentrations to determine the pharmacokinetic parameters of Caspofungin in patients with liver failure', 'timeFrame': '14 days', 'description': 'one dose of caspofungin will be given to patients with hepatic failure. Serum sampling will be performed during 96 hours. Measurements of caspofungin in the serum will be performed to study the pharmacokinetics of this drugs and will be compared with pharmacokinetics of subjects with normal liver function. For safety, patients will be followed during 14 days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bacterial Infections and Mycoses', 'Liver Disease']}, 'referencesModule': {'references': [{'pmid': '29860319', 'type': 'RESULT', 'citation': 'Gustot T, Ter Heine R, Brauns E, Cotton F, Jacobs F, Bruggemann RJ. Caspofungin dosage adjustments are not required for patients with Child-Pugh B or C cirrhosis. J Antimicrob Chemother. 2018 Sep 1;73(9):2493-2496. doi: 10.1093/jac/dky189.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to conduct a population pharmacokinetic analysis of caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis or liver disease with Child-Pugh score B and C in order to better characterize pharmacokinetic parameters in case of moderate and severe liver dysfunction.', 'detailedDescription': 'patients admitted for alcoholic hepatitis or decompensated cirrhosis and Child-Pugh score 7-9 and 10-15 will be included; all patients without invasive aspergillosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver failure Child-Pugh B and C\n\nExclusion Criteria:\n\n* Cachexia (BMI \\< 15 kg/m²)\n* Pregnancy\n* HIV\n* Hepatitis C patients'}, 'identificationModule': {'nctId': 'NCT01968395', 'briefTitle': 'Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure', 'orgStudyIdInfo': {'id': 'E2013_PK_CASPO70_LIVERFAILURE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Caspofungin 70 mg', 'description': 'Infusion of one dose of Caspofungin 70 mg', 'interventionNames': ['Drug: Caspofungin 70 mg']}], 'interventions': [{'name': 'Caspofungin 70 mg', 'type': 'DRUG', 'otherNames': ['Cancidas'], 'description': 'Intravenous use', 'armGroupLabels': ['Caspofungin 70 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme University Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Frédérique JACOBS, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasme University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}