Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-03-29 @ 6:22 PM
Study NCT ID:
NCT00629603
Status:
COMPLETED
Last Update Posted:
2013-04-18
First Post:
2008-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016207', 'term': 'Cytokines'}], 'ancestors': [{'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-17', 'studyFirstSubmitDate': '2008-02-26', 'studyFirstSubmitQcDate': '2008-03-05', 'lastUpdatePostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cytokine gene polymorphism on disease severity', 'timeFrame': 'years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatitis C virus infection', 'chronic liver disease', 'fibrosis-related cytokine'], 'conditions': ['Fibrosis', 'Chronic Liver Disease']}, 'descriptionModule': {'briefSummary': 'Hepatitis C virus (HCV) infection causes different disease spectrum ranging from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma. Evidence indicates that host genetic factor may play a role in determining disease progression. It is known that many cytokine polymorphisms affect disease progressin via increasing hepatic fibrosis that are key factors in progressing liver injury. By combinations of fibrosis-relating gene polymorphisms, this study aims to identify patients with high risk for progressive liver disease. These patients need intensive therapy to decrease morbidity and mortality of chronic HCV-related liver disease.', 'detailedDescription': 'Determination of the following fibrosis-relating gene polymorphisms in HCV-related chronic liver disease and HCC will be performed: TNF-α , TNF-β, Factor V Leiden, TGF-β1, PDGF-B gene, Angiotensinogen (AT),Angiotensin converting enzyme (ACE), microsomal epoxide hydrolase (mEH) and glutathione-S-transferase (GST).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with anti-HCV positive\n\nExclusion Criteria:\n\n* Anti-HCV-negative patients'}, 'identificationModule': {'nctId': 'NCT00629603', 'briefTitle': 'Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease', 'orgStudyIdInfo': {'id': 'KMUH-IRB-950347'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cytokine polymorphisms, HCV infection', 'description': 'Relate the fibrosis cytokine gene polymorphisms with disease severity of HCV-related chronic liver disease', 'interventionNames': ['Genetic: cytokine', 'Genetic: cytokine polymorphisms', 'Genetic: cytokine polymorphism']}], 'interventions': [{'name': 'cytokine', 'type': 'GENETIC', 'otherNames': ['hepatitis C virus infection', 'cytokine polymorphism', 'fibrosis'], 'description': 'polymorphisms of fibrosis-relating cytokine were measured to validate the effectiveness of fibrosis in HCV-related chronic liver disease', 'armGroupLabels': ['cytokine polymorphisms, HCV infection']}, {'name': 'cytokine polymorphisms', 'type': 'GENETIC', 'otherNames': ['hepatitis C virus infection', 'cytokine polymorphism', 'fibrosis'], 'description': 'Fibrosis-relating cytokine polymorphisms in hepatitis C virus-related chronic liver disease were measured to validate the degree of fibrosis', 'armGroupLabels': ['cytokine polymorphisms, HCV infection']}, {'name': 'cytokine polymorphism', 'type': 'GENETIC', 'otherNames': ['hepatitis C virus infection', 'cytoline polymorphism', 'fibrosis'], 'description': 'fibrosis-relating cytokine polymorphism', 'armGroupLabels': ['cytokine polymorphisms, HCV infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'state': 'Kaohsiung', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '807', 'city': 'Kaohsiung City', 'state': 'Kaohsiung', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Jung-Fa Tsai, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Jung-Fa,Tsai (1)', 'investigatorAffiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}}}}