Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-02 @ 2:01 AM
Study NCT ID:
NCT03566966
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2018-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autoantibodies and Direct-acting Antivirals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples for antibodies determination'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}, 'targetDuration': '24 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-02', 'studyFirstSubmitDate': '2018-06-11', 'studyFirstSubmitQcDate': '2018-06-21', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virological response', 'timeFrame': '24 weeks after the end of antiviral therapy', 'description': 'Evaluation of HCV-RNA levels'}], 'secondaryOutcomes': [{'measure': 'Disappearance of non-organ-specific antibodies', 'timeFrame': '24 weeks after the end of antiviral therapy', 'description': 'Evaluation of anti nuclear antibodies, anti smooth muscle antibodies, liver kidney microsome antibodies'}, {'measure': 'Side effects', 'timeFrame': '24 weeks after the end of antiviral therapy', 'description': 'Clinical manifestations and laboratory alterations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatitis C virus infection', 'non-organ-specific antibodies', 'prognostic value', 'sustained virological response'], 'conditions': ['Viral Hepatitis C', 'Therapy Adverse Effect']}, 'referencesModule': {'references': [{'pmid': '30375693', 'type': 'DERIVED', 'citation': 'Shahini E, Iannone A, Romagno D, Armandi A, Carparelli S, Principi M, Viggiani MT, Ierardi E, Di Leo A, Barone M. Clinical relevance of serum non-organ-specific antibodies in patients with HCV infection receiving direct-acting antiviral therapy. Aliment Pharmacol Ther. 2018 Nov;48(10):1138-1145. doi: 10.1111/apt.14999.'}]}, 'descriptionModule': {'briefSummary': 'The investigators assessed non-organ-specific antibodies before and 24 weeks after the end of therapy with direct-acting antivirals, in order to better clarify the clinical relevance of these antibodies in terms of treatment response and prognostic value.\n\nTo achieve this goal patients with hepatitis C virus related advanced liver disease, with detectable circulating autoantibodies on at least two determinations before treatment, were enrolled.', 'detailedDescription': 'About 40-70% of hepatitis C virus patients develop at least an autoimmune extra-hepatic disorder presumably due to the interaction between hepatitis C virus E2 envelope protein and B lymphocyte Cluster of Differentiation-81 receptor. In addition, the same interaction is responsible for the production of different serum non-organ-specific antibodies. The clinical significance of the latter phenomenon has not been fully understood except for the presence of liver kidney microsome-1 antibody, which is linked to a molecular mimicry between the cytochrome enzyme CYP2D6, primarily expressed in the liver, and hepatitis C virus proteins in genetically predisposed subjects.\n\nActually, no data are available about the prevalence and clinical significance of serum non-organ-specific antibodies in hepatitis C virus patients treated with second generation direct-acting antivirals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caucasian patients affected by chronic hepatitis C virus infection who were consecutively admitted as outpatients to the Gastroenterology Unit, Policlinic Hospital, Bari, Italy, from July 2015-August 2016 to receive a treatment with second generation direct-acting antivirals.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nHCV positive patients Presence of advanced liver fibrosis Eligibility to the treatment with direct-acting antiviral therapy.\n\nExclusion Criteria:\n\nHistory of autoimmune hepatitis and/or cholangitis Evidence of active hepatocellular carcinoma Human immunodeficiency virus coinfection Hepatitis B virus coinfection.'}, 'identificationModule': {'nctId': 'NCT03566966', 'acronym': 'BIOEPA', 'briefTitle': 'Autoantibodies and Direct-acting Antivirals', 'organization': {'class': 'OTHER', 'fullName': 'University of Bari'}, 'officialTitle': 'Clinical Relevance of Serum Non-organ-specific Antibodies in Hepatitis C Virus Patients Receiving Direct-acting Antiviral Therapy', 'orgStudyIdInfo': {'id': 'Policlinic Hospital 3, Bari'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-organ-specific Ab positive', 'description': 'Patients who had detectable circulating autoantibodies before treatment with antivirals.', 'interventionNames': ['Biological: Non-organ-specific Ab positive']}, {'label': 'Non-organ-specific Ab negative', 'description': 'Patients who did not have detectable circulating autoantibodies before treatment with antivirals.', 'interventionNames': ['Biological: Non-organ-specific Ab negative']}], 'interventions': [{'name': 'Non-organ-specific Ab positive', 'type': 'BIOLOGICAL', 'otherNames': ['direct-acting antiviral agents'], 'description': 'Antiviral administration and evaluation of SVR24 and side effects', 'armGroupLabels': ['Non-organ-specific Ab positive']}, {'name': 'Non-organ-specific Ab negative', 'type': 'BIOLOGICAL', 'description': 'direct-acting antiviral agents', 'armGroupLabels': ['Non-organ-specific Ab negative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Policlinic Hospital', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'overallOfficials': [{'name': 'Alfredo Di Leo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bari'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It depends on the possibility to merge similar data and produce a multicentric study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Michele Barone', 'investigatorAffiliation': 'University of Bari'}}}}