Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT00375661
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2006-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007438', 'term': 'Introns'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D021901', 'term': 'DNA, Intergenic'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2006-09-12', 'studyFirstSubmitQcDate': '2006-09-12', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse effect of interferon', 'timeFrame': 'During the treatment period'}]}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma'], 'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether low-dose peg-interferon plus ribavirin therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had the curative resection of primary HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Hepatocellular carcinoma due to Chronic Hepatitis C Virus Infection.\n* Must be treated with curative treatment for primary tumor using either surgical resection or radiofrequency ablation therapy\n\nExclusion Criteria:\n\n* No recurrence of hepatocellular carcinoma 3 months after the primary treatment\n* Renal dysfunction'}, 'identificationModule': {'nctId': 'NCT00375661', 'briefTitle': 'Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto University Hospital'}, 'officialTitle': 'Phase 4 Study of Peg-interferon Plus Ribavirin Therapy for Prevention of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'O2006-415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'interferon', 'interventionNames': ['Drug: interferon-alfa-2b and ribavirin']}], 'interventions': [{'name': 'interferon-alfa-2b and ribavirin', 'type': 'DRUG', 'description': 'Interferon, pnce per week plus daily ribavirin', 'armGroupLabels': ['interferon']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kyoto', 'country': 'Japan', 'facility': 'Department of Gastroenterology and Hepatology, Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Red Cross Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Tsutomu Chiba, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyoto University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyoto University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Hiroyuki Marusawa', 'investigatorAffiliation': 'Kyoto University'}}}}