Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04287920
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2020-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Acamprosate Safe to Use in Individuals With Liver Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Simonetto.Douglas@mayo.edu', 'phone': '507-284-4824', 'title': 'Douglas (Doug) A. Simonetto, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline to end of study, approximately 24 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20', 'description': 'The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.\n\nAcamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alcohol-related Liver Disease and AUD, MELD-NA More Than 20', 'description': 'The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20.\n\nAcamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20', 'description': 'The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.\n\nAcamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months'}, {'id': 'OG001', 'title': 'Alcohol-related Liver Disease and AUD, MELD-NA More Than 20', 'description': 'The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20.\n\nAcamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Number of adverse events reported', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'One MELD-NA less than 20 subject and four MELD-NA more than 20 subjects withdrew prior to initiating the study drug. Data was not collected nor analyzed for those 5 subjects'}, {'type': 'SECONDARY', 'title': 'Change in Alcohol Craving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20', 'description': 'The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.\n\nAcamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months'}, {'id': 'OG001', 'title': 'Alcohol-related Liver Disease and AUD, MELD-NA More Than 20', 'description': 'The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20.\n\nAcamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, week 24', 'description': 'Number of subjects who experienced a decrease or unchanged Pennsylvania Alcohol Craving Scale (PACS) score from baseline to week 24. Measured using self-reported questionnaire using Pennsylvania Alcohol Craving Scale (PACS). The PACS has 5 questions, where each question has six options presented in Likert Scales from 0 to 6, with 0 being the least and 6 being the highest possible option, thus the possible minimum and maximum values are 0 and 30, respectively. Higher score indicates a positive alcohol craving symptom.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One MELD-NA less than 20 subject and four MELD-NA more than 20 subjects withdrew prior to initiating the study drug. Data was not collected nor analyzed for those 5 subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20', 'description': 'The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.\n\nAcamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months'}, {'id': 'FG001', 'title': 'Alcohol-related Liver Disease and AUD, MELD-NA More Than 20', 'description': 'The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20.\n\nAcamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20', 'description': 'The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.\n\nAcamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months'}, {'id': 'BG001', 'title': 'Alcohol-related Liver Disease and AUD, MELD-NA More Than 20', 'description': 'The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20.\n\nAcamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '43.00', 'upperLimit': '55.25'}, {'value': '50', 'groupId': 'BG001', 'lowerLimit': '41.75', 'upperLimit': '56.75'}, {'value': '50', 'groupId': 'BG002', 'lowerLimit': '41.25', 'upperLimit': '57.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-25', 'size': 460225, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-28T14:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-29', 'studyFirstSubmitDate': '2020-01-31', 'resultsFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-29', 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event', 'timeFrame': '24 weeks', 'description': 'Number of adverse events reported'}], 'secondaryOutcomes': [{'measure': 'Change in Alcohol Craving', 'timeFrame': 'Baseline, week 24', 'description': 'Number of subjects who experienced a decrease or unchanged Pennsylvania Alcohol Craving Scale (PACS) score from baseline to week 24. Measured using self-reported questionnaire using Pennsylvania Alcohol Craving Scale (PACS). The PACS has 5 questions, where each question has six options presented in Likert Scales from 0 to 6, with 0 being the least and 6 being the highest possible option, thus the possible minimum and maximum values are 0 and 30, respectively. Higher score indicates a positive alcohol craving symptom.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol-related Liver Disease']}, 'referencesModule': {'references': [{'pmid': '40136257', 'type': 'DERIVED', 'citation': 'Wu T, Mousa OY, Kulai T, Larson C, Olofson A, Kamath PS, Shah VH, Taner T, Sanchez W, Simonetto DA. Safety of Acamprosate in Patients With Alcohol-Associated Liver Disease: A Single-Arm Phase 2 Trial. Mayo Clin Proc. 2025 Jun;100(6):954-961. doi: 10.1016/j.mayocp.2024.12.013. Epub 2025 Mar 26.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Is acamprosate safe to use in individuals with liver disease.', 'detailedDescription': 'Adult patients aged 21 or over with a diagnosis of alcohol-related liver disease and alcohol use disorder (AUD) and abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Aged 21 or over\n* Diagnosis of alcohol-related liver disease and AUD.\n\n * The diagnosis of alcohol-related liver disease will be determined by a hepatologist based on history of regular and excessive alcohol consumption in the absence of other causes of liver cirrhosis or acute hepatitis, compatible clinical, imaging and laboratory findings and typical histology on liver biopsy, if performed. Underlying liver disease may include alcoholic hepatitis, advanced (F3-F4) fibrosis, and/or portal hypertension.\n * The diagnosis of AUD will be determined by a hepatologist and/or addiction psychiatrist based on history obtained that is consistent with DSM-5 diagnostic criteria for AUD (all categories of mild, moderate and severe considered eligible) (American Psychiatric Association, 2013; questions from NIH, 2016).\n* Abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.\n* At study enrollment, initial MELD-Na score must be less than 20 for the five individuals enrolling in the first phase of the pilot safety assessment. The second phase of the pilot safety assessment will include individuals with a MELD-Na of 20 or more at enrollment.\n* Have capacity to provide consent themselves\n\nExclusion criteria:\n\n* Individuals with a glomerular filtration rate (GFR) of less than 30 ml/min\n* Congestive heart failure (NYHA class II or higher)\n* Hypotension, requiring the use of vasoconstrictors (i.e. midodrine)\n* Pregnancy, lactation or refusal to use a reliable method of birth control if a sexually active female of childbearing potential. Although no human trial data is available, animal studies suggest possible teratogenic effects of acamprosate (Merck, 2005).'}, 'identificationModule': {'nctId': 'NCT04287920', 'briefTitle': 'Acamprosate Safe to Use in Individuals With Liver Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Phase II Study Evaluating the Safety of Acamprosate for Alcohol Use Disorder in Alcohol-related Liver Disease', 'orgStudyIdInfo': {'id': '18-010902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol-related liver disease and AUD, MELD-NA less than 20', 'description': 'The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.', 'interventionNames': ['Drug: Acomprosate']}, {'type': 'EXPERIMENTAL', 'label': 'Alcohol-related liver disease and AUD, MELD-NA more than 20', 'description': 'The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20.', 'interventionNames': ['Drug: Acomprosate']}], 'interventions': [{'name': 'Acomprosate', 'type': 'DRUG', 'description': 'Acamprosate will be administered orally and will be dosed at 333 mg three times a day, if tolerated it will be increased to 666 mg three times a day. Acamprosate will be administered for a total of 3 months', 'armGroupLabels': ['Alcohol-related liver disease and AUD, MELD-NA less than 20', 'Alcohol-related liver disease and AUD, MELD-NA more than 20']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Douglas A Simonetto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Douglas (Doug) A. Simonetto', 'investigatorAffiliation': 'Mayo Clinic'}}}}