Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-01 @ 7:56 AM
Study NCT ID:
NCT00674492
Status:
COMPLETED
Last Update Posted:
2015-05-15
First Post:
2008-05-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hepatitis C Virus (HCV) Treatment Completion or Withdrawal
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jack.Clark@va.gov', 'phone': '781.687.2937', 'title': 'Jack A. Clark, PhD', 'organization': 'Center for Healthcare Organization and Implementation Research'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'patients who initiated antiviral treatment for hepatitis C', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Attributes of Treatment Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'patients who initiated antiviral treatment for hepatitis C'}], 'classes': [{'title': 'Avoid Bad End', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Perseverence', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Achieve Cure', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Redemption', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Zero to five years since ending treatment.', 'description': 'Four basic reasons for persisting in antiviral treatment were identified: cure the disease, concern about diminishing time to act (avoid bad end), demonstation of personal strength, and redemption for past behavior.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'patients who initiated antiviral treatment for hepatitis C'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'patients who initiated antiviral treatment for hepatitis C'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '69'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'patients who initiated antiviral treatment'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2008-05-06', 'resultsFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2008-05-07', 'lastUpdatePostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-20', 'studyFirstPostDateStruct': {'date': '2008-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attributes of Treatment Experience', 'timeFrame': 'Zero to five years since ending treatment.', 'description': 'Four basic reasons for persisting in antiviral treatment were identified: cure the disease, concern about diminishing time to act (avoid bad end), demonstation of personal strength, and redemption for past behavior.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': "Qualitative pilot study of patients' views of their experience with antiviral treatment for hepatitis C.", 'detailedDescription': "Qualitative pilot study of patient' views of their experiences with antiviral treatment for hepatitis C. Two groups of patients will be sampled: nine who completed a 24 or 48 week course of treatment and nine who withdrew from treatment prior to planned end. Interview data will be analyzed using narrative and grounded theory methods to identify attributes of treatment experience that may discriminate between completion and withdrawal."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'VHA patients who ever initiated antiviral treatment for hepatitis C.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEver initiated anitiviral treatment for hepatitis C.\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT00674492', 'briefTitle': 'Hepatitis C Virus (HCV) Treatment Completion or Withdrawal', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': "Patients' View of Hepatitis C Treatment Completion or Withdrawal", 'orgStudyIdInfo': {'id': 'SHP 08-193'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hepatitis C patients', 'description': 'patients who initiated antiviral treatment for hepatitis C'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01730', 'city': 'Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA', 'geoPoint': {'lat': 42.49065, 'lon': -71.27617}}], 'overallOfficials': [{'name': 'Jack A Clark, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}