Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-04-17 @ 9:34 AM
Study NCT ID:
NCT02084160
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2014-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'avrahamh@exalenz.com', 'phone': '972-8-9737500', 'title': 'Avrahm Hershkowitz/ Clinical Trial Manager', 'organization': 'Exalenz'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Not relevant, observational, retrospective', 'description': 'Not relevant, observational, retrospective', 'eventGroups': [{'id': 'EG000', 'title': 'CLD From HIS-EX-408/PLT-BID-1108', 'description': 'Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hepatic Decompensation Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '579', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CLD From HIS-EX-408/PLT-BID-1108', 'description': 'Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108'}], 'classes': [{'categories': [{'measurements': [{'value': '324', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Hepatic decompensation is defined as the occurrence of at least one of the following events in the time frame between the last 13C Methacetin Breath Test (MBT) to the time of data collection:\n\n1. Death (liver related)\n2. Transplantation (cadaveric and living donors)\n3. Ascites\n4. HE (Hepatic Encephalopathy)\n5. Newly diagnosed varices or variceal bleeding\n6. SBP (spontaneous bacterial peritonitis)\n7. HRS (Hepatorenal syndrome)\n8. HCC (hepatocellular carcinoma)\n9. Increase in CTP (Child Turcotte Pugh) Score by 3 points\n10. Increase in MELD score by 5 points', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with advanced chronic liver disease'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CLD From HIS-EX-408/PLT-BID-1108', 'description': 'Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '579'}]}, {'type': 'COMPLETED', 'comment': '579 patient records were reviewed for follow up events, only a small portion had events to report', 'achievements': [{'groupId': 'FG000', 'numSubjects': '579'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '579', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CLD From HIS-EX-408/PLT-BID-1108', 'description': 'Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '579', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '52.55', 'spread': '10.67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '579', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '237', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '342', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '579', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '418', 'groupId': 'BG000'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '579', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects that were in previous trials NCT: NCT00736840 and NCT01157845'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-01', 'size': 1383363, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-26T08:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 579}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-19', 'studyFirstSubmitDate': '2014-03-09', 'resultsFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2014-03-09', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-26', 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic Decompensation Event', 'timeFrame': '5 years', 'description': 'Hepatic decompensation is defined as the occurrence of at least one of the following events in the time frame between the last 13C Methacetin Breath Test (MBT) to the time of data collection:\n\n1. Death (liver related)\n2. Transplantation (cadaveric and living donors)\n3. Ascites\n4. HE (Hepatic Encephalopathy)\n5. Newly diagnosed varices or variceal bleeding\n6. SBP (spontaneous bacterial peritonitis)\n7. HRS (Hepatorenal syndrome)\n8. HCC (hepatocellular carcinoma)\n9. Increase in CTP (Child Turcotte Pugh) Score by 3 points\n10. Increase in MELD score by 5 points'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Liver Disease']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are:\n\n* To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events\n* To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT has a better predictive ability of clinical outcome than liver biopsy.\n* To evaluate the ability of the MBT to predict each of the individual liver related complications.', 'detailedDescription': 'Exalenz has previously gathered information in a previous study on patients with chronic liver disease including the methacetin breath test. Several years later, the company wishes to investigate this group of subjects and see retrospectively if the breath test was a predictor of complications related to their liver disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408"', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects that aere enrolled in the previous Exalenz trial HIS-EX-408 or PLT-BID-1108\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT02084160', 'briefTitle': 'Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meridian Bioscience, Inc.'}, 'officialTitle': 'The Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation; a Retrospective Analysis', 'orgStudyIdInfo': {'id': 'HIS-FU-EX-1213'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CLD from HIS-EX-408/PLT-BID-1108', 'description': 'Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Origanzation', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Taufick Chori, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meridian Bioscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}