Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT04173520
Status:
COMPLETED
Last Update Posted:
2019-11-26
First Post:
2019-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ELRIAH Score: A Simple Score for HCC Risk Stratification in CHC Patients With Cirrhosis or Advanced Liver Fibrosis Who Achieved SVR Following DAA Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000849', 'term': 'bis(p-chlorophenyl)acetic acid'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2326}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-22', 'studyFirstSubmitDate': '2019-11-17', 'studyFirstSubmitQcDate': '2019-11-19', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of HCC incidence after viral clearance', 'timeFrame': '12-45 months after SVR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HCC']}, 'descriptionModule': {'briefSummary': 'aimed to develop a scoring system to assess risk of developing HCC in a large cohort of chronic hepatitis C (CHC) patients with advanced hepatic fibrosis (F3) or cirrhosis (F4) with sustained virological response (SVR) after receiving direct acting antivirals (DAAs).', 'detailedDescription': 'Current guidelines recommend biannual surveillance for hepatocellular carcinoma (HCC) in all patients with cirrhosis. However, risk of HCC incidence is not the same for different patients. The study aimed to develop a scoring system to assess risk of developing HCC in a large cohort of chronic hepatitis C (CHC) patients with advanced hepatic fibrosis (F3) or cirrhosis (F4) with sustained virological response (SVR) after receiving direct acting antivirals (DAAs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '2326 CHC patients (638 patients with F3 and 1734 with F4 stage)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no history of previous HCC\n* SVR after DAAs treatment\n\nExclusion Criteria:\n\n* history of previous HCC'}, 'identificationModule': {'nctId': 'NCT04173520', 'briefTitle': 'ELRIAH Score: A Simple Score for HCC Risk Stratification in CHC Patients With Cirrhosis or Advanced Liver Fibrosis Who Achieved SVR Following DAA Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Egyptian Liver Hospital'}, 'officialTitle': 'ELRIAH Score: A Simple Score for HCC Risk Stratification in CHC Patients With Cirrhosis or Advanced Liver Fibrosis Who Achieved SVR Following DAA Therapy', 'orgStudyIdInfo': {'id': 'SCORE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DDA', 'type': 'DRUG', 'description': 'Follow up after SVR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egyptian Liver Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}