Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-06 @ 8:27 PM
Study NCT ID:
NCT02578693
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum/Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2015-10-16', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virological response (SVR)', 'timeFrame': '36 months', 'description': 'The primary outcome measure is the occurence (yes or no) of sustained virologic response (SVR), defined as HCV RNA \\< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various patients receiving IFN or DAAs based treatment.'}], 'secondaryOutcomes': [{'measure': 'Treatment persistence', 'timeFrame': '36 months', 'description': 'Treatment persistence will be the duration of treatment measured from the first dose of medication until treatment is discontinued. Reasons for premature discontinuation of treatment will be recorded.'}, {'measure': 'Virological breakthrough', 'timeFrame': '36 months', 'description': 'The occurrence of virological breakthrough defined as an increase of HCV RNA by at least 1-log over nadir or to \\>100 IU if previously undetectable.'}, {'measure': 'Liver disease progression', 'timeFrame': 'Post treatment 10 years', 'description': 'Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.'}, {'measure': 'Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen', 'timeFrame': 'Post treatment 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Hepatitis C Infection']}, 'descriptionModule': {'briefSummary': 'The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic hepatitis C treated with interferon-based therapy or direct-acting agents (DAAs)-based regimen;\n* Provide written, informed consent;\n* Be willing and able to comply with the visit schedule and protocol-mandated procedures.\n\nExclusion Criteria:\n\n* Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up time frame;\n* History of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol.\n* Inability to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT02578693', 'briefTitle': 'Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)', 'organization': {'class': 'OTHER', 'fullName': 'Humanity and Health Research Centre'}, 'officialTitle': 'Long Term Follow-up for Subjects With Chronic Hepatitis C Infection Who Received Interferon-based Therapy or Direct-acting Antiviral Agents (DAAs)-Based Therapy', 'orgStudyIdInfo': {'id': 'H&H_HCV IFN Vs DAAs Fu'}}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '00852', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Humanity and Health GI and Liver Centre', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '400-8506', 'city': 'Kofu', 'state': 'Yamanashi', 'country': 'Japan', 'facility': 'Yamanashi Prefectural Central Hospital', 'geoPoint': {'lat': 35.66667, 'lon': 138.56667}}], 'overallOfficials': [{'name': 'George Lau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanity & Health Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanity and Health Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'Yamanashi Prefectural Central Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}