Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-30 @ 2:32 AM
Study NCT ID:
NCT01342003
Status:
COMPLETED
Last Update Posted:
2011-04-26
First Post:
2011-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'HCVRNA determination was performed quantitatively before the treatment (TaqMan Roche Diagnostics). The TaqMan value utilized to determine the response was 15 IU/ml. TaqMan method was a standardized method utilized from December 2007 in all the center of the CLEO group. HCVRNA value was expressed as log10 IU/ml.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-25', 'studyFirstSubmitDate': '2011-04-25', 'studyFirstSubmitQcDate': '2011-04-25', 'lastUpdatePostDateStruct': {'date': '2011-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end point was sustained undetectable serum HCVRNA 24 weeks after treatment cessation (SVR).', 'timeFrame': '24 weeks after treatment cessation', 'description': 'The primary end point was sustained undetectable serum HCVRNA 24 weeks after treatment cessation (Sustained virological response).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HCV infection', 'genotype 1a', 'genotype 1 b'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '23157720', 'type': 'DERIVED', 'citation': "Pellicelli AM, Romano M, Stroffolini T, Mazzoni E, Mecenate F, Monarca R, Picardi A, Bonaventura ME, Mastropietro C, Vignally P, Andreoli A, Marignani M, D'Ambrosio C, Miglioresi L, Nosotti L, Mitidieri O, Gentilucci UV, Puoti C, Barbaro G, Barlattani A, Furlan C, Barbarini G; CLEO Group. HCV genotype 1a shows a better virological response to antiviral therapy than HCV genotype 1b. BMC Gastroenterol. 2012 Nov 16;12:162. doi: 10.1186/1471-230X-12-162."}], 'seeAlsoLinks': [{'url': 'http://www.scamilloforlanini.rm.it', 'label': 'web site of AO SCamillo Forlanini Hospital'}]}, 'descriptionModule': {'briefSummary': 'Sustained virological response (SVR) to antiviral therapy in patients with chronic hepatitis C genotype 1 according to subtype (1a vs.1b) has not been extensively investigated. This observational study was carried out on a large group of "naïve" HCV patients to evaluate difference, if any, between HCV genotype 1 subtype 1a and 1b on the response to treatment with peginterferon (Peg-IFN) plus ribavirin.', 'detailedDescription': 'Despite the challenging perspective of the new antiviral drugs directly acting on hepatitis C viral replication such as protease and polymerase inhibitors, nowadays the standard treatment in genotype 1-chronic hepatitis C (CHC) is the combination of peghylated interferon (PEG-IFN) and ribavirin for 48 weeks. It has been extensively shown that patients infected with HCV genotype 1 have a lower rate of viral response than those infected with genotype 2 and 3. In large randomized multinational trials, sustained virological response (SVR) of around 50% has been obtained with peginterferon α2a plus ribavirin in the more difficult to treat subgroup of patients infected with HCV genotype 1. Furthermore, advanced fibrosis is a predictive factor of non response to antiviral treatment in genotype 1 virus \\[5-7\\]. Very few studies have evaluated SVR difference, if any, between subtypes 1a and 1b.\n\nWe have carried out an observational study on a large cohort of HCV "naïve" patients to evaluate the influence of HCV subtypes 1 on the response to treatment with Peg-INF plus ribavirin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Three hundred and eighty-eight patients were included in the study. One hundred and sixty-five were HCV genotype 1 subtype 1a (42.5%) while two hundred twenty-three were of subtype 1b (57.5%).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eligible subjects were naïve infected with HCV genotype 1 virus meeting the internationally recognised criteria for treatment (elevation of aminotransferases, inflammation and or fibrosis at liver biopsy).\n\nExclusion Criteria:\n\n* infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)\n* alcohol intake greater than 20 gr daily\n* the presence of active drug abuse, chronic systemic disease, psychiatric disorders, autoimmune disease, pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT01342003', 'acronym': 'genotype', 'briefTitle': 'HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera San Camillo Forlanini'}, 'officialTitle': 'HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b', 'orgStudyIdInfo': {'id': '01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subtype 1a', 'description': 'subtype 1a patients treated with peginterferon plus ribavirin'}, {'label': 'subtype 1b', 'description': 'subtype 1b patients treated with peginterferon plus ribavirin'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00142', 'city': 'Rome', 'state': 'Italy', 'country': 'Italy', 'facility': 'AO San Camillo Forlanini', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Adriano M Pellicelli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AO Scamilloforlanini Rome Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera San Camillo Forlanini', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Adriano M Pellicelli', 'oldOrganization': 'AO San Camillo Forlanini'}}}}