Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT00059202
Status:
TERMINATED
Last Update Posted:
2021-05-03
First Post:
2003-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of High-dose Urso in Primary Sclerosing Cholangitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}], 'ancestors': [{'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '507-284-2511', 'title': 'Dr. Keith Lindor', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Five years', 'eventGroups': [{'id': 'EG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'deathsNumAffected': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo for Urso', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Treatment failure was defined as death, transplantation, meeting minimal listing criteria, development of varices, cholangiocarcinoma, or progression to cirrhosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo or Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Death at any time up to 5 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Have a Liver Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic acid 28-30 mg/kg/day\n\nUrsodeoxycholic Acid: Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Liver transplantation at any time up to 5 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting Minimal Listing Criteria for Liver Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Meeting minimal listing criteria for liver transplantation at any time up to 5 years. Minimal listing criteria are defined as a MELD score of 14 or higher. The Model For End-Stage Liver Disease (MELD) is a numeric score with a range of 6 to 40, where a higher score means worse liver disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Developed Cholangiocarcinoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Development of cholangiocarcinoma at any time up to 5 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Developed Varices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Development of esophogeal and/or gastric varices', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Developed Cirrhosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Development of cirrhosis based on liver biopsy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alkaline Phosphatase at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '9.1'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '13.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'Alkaline phosphatase divided by the upper limit of normal', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alkaline Phosphatase at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '8.5'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '11.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 months', 'description': 'Alkaline phosphatase divided by the upper limit of normal', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alkaline Phosphatase at 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '16.5'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '12.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '36 months', 'description': 'Alkaline phosphatase divided by the upper limit of normal', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aspartate Aminotransferase at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '10.5'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '8.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'Aspartate aminotransferase at divided by the upper limit of normal', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aspartate Aminotransferase at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '8.4'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '13.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 months', 'description': 'Aspartate aminotransferase at divided by the upper limit of normal', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aspartate Aminotransferase at 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '7.2'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '14.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '36 months', 'description': 'Aspartate aminotransferase at divided by the upper limit of normal', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bilirubin at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.3'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '8.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'Bilirubin divided by the upper limit of normal', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bilirubin at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '7.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '8.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 months', 'description': 'Bilirubin divided by the upper limit of normal', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bilirubin at 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '15.9'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '9.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '36 months', 'description': 'Bilirubin divided by the upper limit of normal', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ursodeoxycholic Acid', 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo for Urso'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.9', 'groupId': 'BG000', 'lowerLimit': '20.5', 'upperLimit': '75.6'}, {'value': '45.3', 'groupId': 'BG001', 'lowerLimit': '17.9', 'upperLimit': '73.6'}, {'value': '46.6', 'groupId': 'BG002', 'lowerLimit': '17.9', 'upperLimit': '75.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'whyStopped': 'DSMB reviewed interim analysis and terminated the study due to futility.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2003-04-21', 'resultsFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2003-04-21', 'lastUpdatePostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-12', 'studyFirstPostDateStruct': {'date': '2003-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Failure', 'timeFrame': '5 years', 'description': 'Treatment failure was defined as death, transplantation, meeting minimal listing criteria, development of varices, cholangiocarcinoma, or progression to cirrhosis'}], 'secondaryOutcomes': [{'measure': 'Number of Deaths', 'timeFrame': '5 years', 'description': 'Death at any time up to 5 years'}, {'measure': 'Number of Participants Who Have a Liver Transplantation', 'timeFrame': '5 years', 'description': 'Liver transplantation at any time up to 5 years'}, {'measure': 'Number of Participants Meeting Minimal Listing Criteria for Liver Transplantation', 'timeFrame': '5 years', 'description': 'Meeting minimal listing criteria for liver transplantation at any time up to 5 years. Minimal listing criteria are defined as a MELD score of 14 or higher. The Model For End-Stage Liver Disease (MELD) is a numeric score with a range of 6 to 40, where a higher score means worse liver disease.'}, {'measure': 'Number of Participants Who Developed Cholangiocarcinoma', 'timeFrame': '5 years', 'description': 'Development of cholangiocarcinoma at any time up to 5 years'}, {'measure': 'Number of Participants Who Developed Varices', 'timeFrame': '5 years', 'description': 'Development of esophogeal and/or gastric varices'}, {'measure': 'Number of Participants Who Developed Cirrhosis', 'timeFrame': '5 years', 'description': 'Development of cirrhosis based on liver biopsy'}, {'measure': 'Alkaline Phosphatase at 12 Months', 'timeFrame': '12 months', 'description': 'Alkaline phosphatase divided by the upper limit of normal'}, {'measure': 'Alkaline Phosphatase at 24 Months', 'timeFrame': '24 months', 'description': 'Alkaline phosphatase divided by the upper limit of normal'}, {'measure': 'Alkaline Phosphatase at 36 Months', 'timeFrame': '36 months', 'description': 'Alkaline phosphatase divided by the upper limit of normal'}, {'measure': 'Aspartate Aminotransferase at 12 Months', 'timeFrame': '12 months', 'description': 'Aspartate aminotransferase at divided by the upper limit of normal'}, {'measure': 'Aspartate Aminotransferase at 24 Months', 'timeFrame': '24 months', 'description': 'Aspartate aminotransferase at divided by the upper limit of normal'}, {'measure': 'Aspartate Aminotransferase at 36 Months', 'timeFrame': '36 months', 'description': 'Aspartate aminotransferase at divided by the upper limit of normal'}, {'measure': 'Bilirubin at 12 Months', 'timeFrame': '12 months', 'description': 'Bilirubin divided by the upper limit of normal'}, {'measure': 'Bilirubin at 24 Months', 'timeFrame': '24 months', 'description': 'Bilirubin divided by the upper limit of normal'}, {'measure': 'Bilirubin at 36 Months', 'timeFrame': '36 months', 'description': 'Bilirubin divided by the upper limit of normal'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urso', 'PSC'], 'conditions': ['Primary Sclerosing Cholangitis']}, 'referencesModule': {'references': [{'pmid': '19585548', 'type': 'RESULT', 'citation': 'Lindor KD, Kowdley KV, Luketic VA, Harrison ME, McCashland T, Befeler AS, Harnois D, Jorgensen R, Petz J, Keach J, Mooney J, Sargeant C, Braaten J, Bernard T, King D, Miceli E, Schmoll J, Hoskin T, Thapa P, Enders F. High-dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis. Hepatology. 2009 Sep;50(3):808-14. doi: 10.1002/hep.23082.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* Chronic cholestatic disease of at least six months' duration.\n* Serum alkaline phosphatase at least 1 ½ times the upper limits of normal.\n* Retrograde, operative, percutaneous, or magnetic resonance cholangiography demonstrating intrahepatic and/or extrahepatic biliary duct obstruction, beading, or narrowing consistent with PSC within one year of the study entry.\n* Liver biopsy in the previous one year which is available for review and compatible with the diagnosis of PSC. Compatible biopsy features include fibrous cholangitis, ductopenia with periportal inflammation and biliary fibrosis."}, 'identificationModule': {'nctId': 'NCT00059202', 'briefTitle': 'Trial of High-dose Urso in Primary Sclerosing Cholangitis', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis', 'orgStudyIdInfo': {'id': 'URSO (completed)'}, 'secondaryIdInfos': [{'id': 'R01DK056924', 'link': 'https://reporter.nih.gov/quickSearch/R01DK056924', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ursodeoxycholic acid', 'description': 'Ursodeoxycholic acid 28-30 mg/kg/day', 'interventionNames': ['Drug: Ursodeoxycholic Acid']}], 'interventions': [{'name': 'Ursodeoxycholic Acid', 'type': 'DRUG', 'otherNames': ['UDCA'], 'description': 'Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses', 'armGroupLabels': ['Ursodeoxycholic acid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for Urso', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Medical College of Virginia', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}