Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-07 @ 11:31 PM
Study NCT ID:
NCT03358420
Status:
UNKNOWN
Last Update Posted:
2017-11-30
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammation and Steatosis: the Role of Alpha-defensin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2017-11-27', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of immunohistochemical stain', 'timeFrame': 'Six months', 'description': 'The amplitude of each slide will be graded from 1-4'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Fatty Liver']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the correlation between the severity of non-alcoholic steatohepatitis/non alcoholic fatty liver disease (NASH/NAFLD) in naïve and hepatitis C (HCV) positive patients and the amplitude of alpha-defensin immunohistochemical staining in liver biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending our liver unit who underwent a liver biopsy with proven fatty liver disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fatty liver disease patients with liver biopsy\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03358420', 'briefTitle': 'Inflammation and Steatosis: the Role of Alpha-defensin', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Inflammation and Steatosis: the Role of Alpha-defensin', 'orgStudyIdInfo': {'id': 'HYMC-103-16'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immunohistochemical staining', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pathological liver slides to be immunohistochemically stained for alpha-defensin'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Rami Abu Fanne, MD', 'role': 'CONTACT', 'email': 'ramia@hadassah.org.il', 'phone': '972-503573694'}], 'facility': 'Hille Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Rami Abu Fanne, MD', 'role': 'CONTACT', 'email': 'ramia@hadassah.org.il', 'phone': '972-50-3573694'}], 'overallOfficials': [{'name': 'Rami Abu Fanne, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}