Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-08 @ 6:37 AM
Study NCT ID:
NCT01513850
Status:
COMPLETED
Last Update Posted:
2015-06-01
First Post:
2012-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-29', 'studyFirstSubmitDate': '2012-01-16', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HBV(HBsAg) recurrence', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Time to recurrence', 'timeFrame': '52 weeks'}, {'measure': 'Survival', 'timeFrame': '52 weeks'}, {'measure': 'viral Marker of HBV', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver Transplantation', 'HBV', 'HBV Recurrence', 'HBsAg Positive'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.', 'detailedDescription': 'A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HBsAg Positive candidate for HBV-related liver transplant\n* Primary, single organ recipients\n* written informed consent\n\nExclusion Criteria:\n\n* acute renal failure, Serum creatinin \\>1.5\\*ULN\n* severe cardiac disease or other significant disease\n* HAV, HCV or HIV positive\n* Immunoglobulin A deficiency.\n* History of hypersensitivity to Human Immunoglobulin.\n* History of cancer within 5 years. (without HCC)\n* History of alcohol or/and drug abuse.\n* History organ transplantation.\n* Within 30 days, participation in another clinical trial and use of an investigational product.\n* Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.'}, 'identificationModule': {'nctId': 'NCT01513850', 'briefTitle': 'A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'A 52-week, Multi-center, Open Label, Single Arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients', 'orgStudyIdInfo': {'id': 'Hepabulin IV_LT_lll_2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hepabulin IV', 'interventionNames': ['Drug: Hepabulin IV']}], 'interventions': [{'name': 'Hepabulin IV', 'type': 'DRUG', 'description': 'I.V.', 'armGroupLabels': ['Hepabulin IV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam', 'state': 'Gyunggi-do', 'country': 'South Korea', 'facility': 'SKChemicals', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'Dong Goo Kim, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "St.Mary's Hospital, Catholic University Medical college"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}