Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT02759861
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595958', 'term': 'ledipasvir, sofosbuvir drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark.mailliard@unmc.edu', 'phone': '402-559-8126', 'title': 'Mark Mailliard', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'description': 'All-Cause Mortality was assessed in the total enrolled population while the Serious and Other (Not including Serious) adverse events were assessed in the completed population.', 'eventGroups': [{'id': 'EG000', 'title': 'Harvoni x 8 or 12 Weeks', 'description': 'patient will receive 8 or 12 weeks depending on clinical data\n\nharvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visit to monitor alcohol and adherence of harvoni therapy', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 16, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Subjects Who Achieve Negative RNA in Alcoholics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Harvoni x 8 or 12 Weeks', 'description': 'patient will receive 8 or 12 weeks depending on clinical data\n\nharvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visit to monitor alcohol and adherence of harvoni therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after the end of Harvoni therapy', 'description': 'Sustained viral response in treatment -naive heavy alcohol drinking patients.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F3/F4', 'description': 'Subjects who had advances fibrosis F3/F4 who achieved SVR at 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after the end of Harvoni therapy', 'description': 'Number of alcoholics with HCV type 1 genotype who had advanced fibrosis F3/F4 who achieve SVR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Had fibrosis F3/F4'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Harvoni x 8 or 12 Weeks', 'description': 'patient will receive 8 or 12 weeks depending on clinical data\n\nharvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visit to monitor alcohol and adherence of harvoni therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Harvoni x 8 or 12 Weeks', 'description': 'patient will receive 8 or 12 weeks depending on clinical data\n\nharvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-01', 'size': 356948, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-19T14:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-27', 'studyFirstSubmitDate': '2016-04-26', 'resultsFirstSubmitDate': '2022-12-27', 'studyFirstSubmitQcDate': '2016-05-02', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-22', 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Subjects Who Achieve Negative RNA in Alcoholics', 'timeFrame': '12 weeks after the end of Harvoni therapy', 'description': 'Sustained viral response in treatment -naive heavy alcohol drinking patients.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR', 'timeFrame': '12 weeks after the end of Harvoni therapy', 'description': 'Number of alcoholics with HCV type 1 genotype who had advanced fibrosis F3/F4 who achieve SVR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Genotype 1 Hepatitis C Virus']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection', 'detailedDescription': 'determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject must be willingly and able to provide written informed consent\n2. Age 19 years of age or older (The age of consent in Nebraska)\n3. HCV treatment-naïve, as defined as no prior exposure to any Interferon (IFN), RBV, or other FDA approved or experimental HCV-specific direct-acting antiviral agent\n4. HCV RNA level at most 6 months prior to the Baseline/Day 1 visit.\n5. HCV genotyping 1a, 1b, or mixed 1a/ab. Any non-definitive results will exclude the subject from study participation.\n6. Alcohol misuse as defined by the Alcohol Use Disorders Identification Test (AUDIT) score subjects must score \\> 8 (associated with harmful or hazardous drinking)\n7. Cirrhosis determination \\[up to 20% of study subjects may have cirrhosis\\]:\n\n 1. Cirrhosis is defined as any one of the following:\n\n * History of a liver biopsy showing cirrhosis (e.g. Metavir score = 4 or Ishak score \\> 5)\n * Fibroscan showing cirrhosis or results \\> 12.5 kPa\n * FIBRO Spect II index consistent with F3 or F4 AND an AST : platelet ration index (APRI) of \\> 2 during Screening\n 2. Absence of cirrhosis is defined as any one of the following:\n\n * Liver biopsy within 2 years of Screening showing absence of cirrhosis\n * Fibroscan within 6 months of Baseline/Day1 with a result of ≤ 12.5 kPa\n * FIBRO Spect II Index consistent with F0- F2 AND APRI of ≤ 1 during Screening\n8. Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma HCC) is required\n9. Subjects must have the following laboratory parameters at screening:\n\n 1. ALT \\< 10 x the upper limit of normal (ULN)\n 2. AST \\< 10 x ULN\n 3. Direct bilirubin \\< 2.0 x ULN\n 4. Platelets \\> 50,000\n 5. HbA1c \\< 8.5%\n 6. Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation\n 7. Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects.\n 8. Albumin ≥ 2.5 g/dL\n 9. INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.\n10. Subject has not been treated with any investigational drug or device within 30 days of the screening visit.\n\nExclusion Criteria:\n\n1. Pregnant women and nursing mothers are ineligible due to the possible risk of adverse effects in the newborn. Eligible patients of reproductive potential should use adequate contraception if sexually active.\n2. Serious concurrent medical illness which would jeopardize the ability of the subject to receive the therapy as outlined in this protocol with reasonable safety.\n3. Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for a malignancy are not eligible.\n4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)\n5. Use of any prohibited concomitant medications within 30 days of the Baseline/Day 1 visit.\n6. Known hypersensitivity to LDV/SOF'}, 'identificationModule': {'nctId': 'NCT02759861', 'briefTitle': 'Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'A Phase IV, Single Arm, Open-Label Study to Determine the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF) in Treatment-Naive Alcoholic Subjects With Chronic Genotype 1 Hepatitis C Infection', 'orgStudyIdInfo': {'id': '0121-16-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Harvoni x 8 or 12 weeks', 'description': 'patient will receive 8 or 12 weeks depending on clinical data', 'interventionNames': ['Drug: harvoni']}], 'interventions': [{'name': 'harvoni', 'type': 'DRUG', 'otherNames': ['Ledipasvir/Sofosbuvir'], 'description': '8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy', 'armGroupLabels': ['Harvoni x 8 or 12 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '680017', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Mark Mailliard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}