Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT00722332
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2008-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C045213', 'term': 'hepatitis B hyperimmune globulin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2008-07-23', 'studyFirstSubmitQcDate': '2008-07-23', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of HepaGam B in combination with antiviral therapy', 'timeFrame': '15 month follow-up'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy', 'timeFrame': '15 month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HBIG (Hepatitis B Immune Globulin)', 'Chronic Hepatitis B Recurrence', 'Liver Transplant'], 'conditions': ['Hepatitis B', 'Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* HBsAg-positive candidates for HBV-related liver transplant\n* Treatment with antiviral therapy before transplantation as per treating physician's recommendation. (NOTE: It is expected that most patients will receive Lamivudine or Adefovir Dipivoxil pre-transplant. In the case of antiviral resistance, an effective alternative antiviral agent(s) must be used.)\n\nExclusion Criteria:\n\n* Multi-organ transplantation recipients\n* Liver re-transplantation except for primary non-function\n* Presence of a hepatoma (larger than 5.0 cm as a solitary node) or 2 to 3 multi-focal nodes (larger than 3.0 cm each) (Milan Criteria) based on information available at baseline visit (CT scan, MRI).\n* Patients requiring an OLT (Orthotopic Liver Transplant)due to fulminant hepatitis B\n* OLT patients receiving a liver graft from a donor that is positive for HBsAg\n* Patients using interferon pre-transplant (as interferon cannot be used post-transplant)\n* History of IgA (immunoglobulin A) deficiency\n* History of hypersensitivity to blood products.\n* HIV or HCV positive\n* Use of an investigational product, or participation in another clinical trial during the course of the study (with the exception of quality-of-life or repository studies)\n* Pregnancy or planned pregnancy during the course of the study"}, 'identificationModule': {'nctId': 'NCT00722332', 'briefTitle': 'Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cangene Corporation'}, 'officialTitle': 'Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients', 'orgStudyIdInfo': {'id': 'HB-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'HBV-related liver transplant patients', 'interventionNames': ['Biological: HepaGam B']}], 'interventions': [{'name': 'HepaGam B', 'type': 'BIOLOGICAL', 'description': 'Hepatitis B Immunoglobulin', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'H2X3J4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cangene Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}