Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-26 @ 5:42 AM
Study NCT ID:
NCT03348059
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2017-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-E1E2 (D32.10 Epitope-binding) Antibodies Status Prior Therapy Favors Direct-acting Antiviral Treatment Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with positive anti-E1E2 antibody level at treatment initiation', 'timeFrame': 'Baseline (treatment initiation day)', 'description': "Anti-E1E2 antibody levels were determined using optical densities obtained after dilution of patients' serum samples at 1/250 and 1/500. Samples with anti-E1E2 levels above 950 (OD value× 1000) were considered positive"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis c']}, 'descriptionModule': {'briefSummary': 'The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological outcome in Hepatitis C virus (HCV)-infected patients receiving direct-acting antiviral treatment', 'detailedDescription': 'Presence of anti-E1E2 antibodies was previously associated with spontaneous cure of hepatitis C virus (HCV). The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological outcome in HCV-infected patients receiving direct-acting antiviral treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hepatitis C virus (HCV)-infected patients treated with direct-acting antiviral treatment', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* HCV patients treated with direct-acting antiviral treatment\n* Patients with a prior treatment blood sample\n* Patients with sustained virological response or virological relapse\n\nExclusion Criteria:\n\n* HIV or hepatitis B virus (HBV) coinfection'}, 'identificationModule': {'nctId': 'NCT03348059', 'briefTitle': 'Anti-E1E2 (D32.10 Epitope-binding) Antibodies Status Prior Therapy Favors Direct-acting Antiviral Treatment Efficacy', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Anti-E1E2 (D32.10 Epitope-binding) Antibodies Status Prior Therapy Favors Direct-acting Antiviral Treatment Efficacy', 'orgStudyIdInfo': {'id': 'CRC_GHN_2017_005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Direct-acting antiviral therapy', 'type': 'DRUG', 'description': 'HCV patients received direct-acting antiviral treatment for 12 or 24 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Croix-Rousse Hospital, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}