Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT06049602
Status:
UNKNOWN
Last Update Posted:
2023-09-22
First Post:
2023-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TDF and Entekavir - Hepatitis B Reactivation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2023-09-15', 'studyFirstSubmitQcDate': '2023-09-15', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reactivation Rate', 'timeFrame': '12 months', 'description': 'Percentage of patients reactivated during the Entekavir or TDF'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B Reactivation']}, 'descriptionModule': {'briefSummary': 'This is a non-interventional retrospective multi-center study for the patients received Entekavir or TDF for Hepatitis B prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who used entekavir or TDF for Hepatitis B prophylaxis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients used entekavir or TDF for Hepatitis B prophylaxis\n\nExclusion Criteria:\n\n* Patients lower then 18 years old.'}, 'identificationModule': {'nctId': 'NCT06049602', 'briefTitle': 'TDF and Entekavir - Hepatitis B Reactivation', 'organization': {'class': 'OTHER', 'fullName': 'Viral Hepatitis Society'}, 'officialTitle': 'Efficacy of TDF and Entekavir Prophylaxis at Hepatitis B Reactivation: Multi Center Retrospective Study', 'orgStudyIdInfo': {'id': 'IMMUNHEP'}}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fehmi Tabak, Prof', 'role': 'CONTACT', 'email': 'fehmitabak@yahoo.com'}, {'name': 'Fehmi Tabak, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cerrahpasa Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Fehmi Tabak, Prof', 'role': 'CONTACT', 'email': 'fehmitabak@yahoo.com', 'phone': '+905322763788'}, {'name': 'Ilker Kurkcu', 'role': 'CONTACT', 'email': 'ilker.kurkcu@sentez-cro.com', 'phone': '+905326354515'}], 'overallOfficials': [{'name': 'Ilker Kurkcu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sentez CRO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viral Hepatitis Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}