Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT01717560
Status:
UNKNOWN
Last Update Posted:
2012-10-30
First Post:
2008-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hepatitis C Treatment in Underserved Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], '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'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-25', 'studyFirstSubmitDate': '2008-04-29', 'studyFirstSubmitQcDate': '2012-10-25', 'lastUpdatePostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.', 'timeFrame': '24 weeks after completion of antiviral treatment', 'description': 'SVR is measured 24 weeks after completion of antiviral treatment'}], 'secondaryOutcomes': [{'measure': 'completion of medical and psychiatric evaluation for antiviral therapy', 'timeFrame': 'Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases.'}, {'measure': 'initiation of antiviral therapy', 'timeFrame': 'Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases.'}, {'measure': 'adherence to antiviral therapy', 'timeFrame': 'Weekly up to 48 weeks', 'description': "Adherence is measured weekly during the duration of prescribed antiviral therapy. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient's characteristics, the regimen, and the response to therapy.)"}, {'measure': 'completion of antiviral therapy', 'timeFrame': 'Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.)'}, {'measure': 'levels of alcohol and illicit drug use', 'timeFrame': 'Weekly up to 96 weeks', 'description': 'Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up'}, {'measure': 'entry into treatment for substance use', 'timeFrame': 'Monthly up to 24 months', 'description': 'Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy'}, {'measure': 'entry into treatment for another unaddressed medical or psychiatric condition', 'timeFrame': 'Monthly up to 24 months', 'description': 'Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy'}, {'measure': 'neuropsychiatric side effects, including depression and hostility/irritability', 'timeFrame': 'Monthly up to 72 weeks', 'description': 'Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter'}, {'measure': 'treatment-limiting systemic, hematologic, or other side effects', 'timeFrame': 'Weekly up to 72 weeks', 'description': 'Measured weekly during prescribed course of antiviral therapy and then monthly or quarterly thereafter (TSH, for example, is measured every 3 months during and after treatment)'}, {'measure': 'other adverse events or adverse effects', 'timeFrame': 'Monthly up to 72 weeks', 'description': 'Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff'}, {'measure': 'reinfection', 'timeFrame': 'Quarterly up to 10 years', 'description': 'Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic hepatitis C', 'illicit drug use', 'Substance-Related Disorders', 'multidisciplinary care', 'integrated care', 'mental health care', 'intensive case management'], 'conditions': ['Chronic Hepatitis C', 'Illicit Drug Use']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.', 'detailedDescription': 'This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Used heroin, cocaine, or injected other drugs for at least 1 year\n* Have used heroin, cocaine and/or methamphetamine within the last 30 days\n* Test positive for HCV antibody\n* Are interested in being evaluated for HCV treatment\n\nExclusion Criteria:\n\n* Persons who are obviously intoxicated, incoherent or otherwise unable to give informed consent are excluded from participation. Such persons may participate in the study if they return at a later date and are capable of providing informed consent.'}, 'identificationModule': {'nctId': 'NCT01717560', 'briefTitle': 'Hepatitis C Treatment in Underserved Populations', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Hepatitis C Treatment in Underserved Populations', 'orgStudyIdInfo': {'id': '0308006281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collaborative multidisciplinary integrated care', 'description': 'Collaborative, multidisciplinary, integrated care for hepatitis C', 'interventionNames': ['Other: Collaborative, multidisciplinary, integrated care']}], 'interventions': [{'name': 'Collaborative, multidisciplinary, integrated care', 'type': 'OTHER', 'description': 'Collaborative, multidisciplinary, integrated care for hepatitis C\n\nmultidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management.', 'armGroupLabels': ['Collaborative multidisciplinary integrated care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Center for the Study of Hepatitis C, Weill Medical College, Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Brian R. Edlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College, Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brian Edlin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, {'name': 'State University of New York - Downstate Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine and Public Health', 'investigatorFullName': 'Brian Edlin', 'investigatorAffiliation': 'Weill Medical College of Cornell University'}}}}