Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-31 @ 5:37 AM
Study NCT ID:
NCT01139203
Status:
UNKNOWN
Last Update Posted:
2010-06-28
First Post:
2010-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'lastUpdateSubmitDate': '2010-06-25', 'studyFirstSubmitDate': '2010-06-07', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2010-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serological markers of HBV', 'timeFrame': 'every three month after liver transplantation', 'description': 'Serological markers of HBV include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA.'}]}, 'conditionsModule': {'keywords': ['HBV recurrence', 'entecavir'], 'conditions': ['Liver Transplantation', 'Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '19373086', 'type': 'BACKGROUND', 'citation': 'Patterson SJ, Angus PW. Post-liver transplant hepatitis B prophylaxis: the role of oral nucleos(t)ide analogues. Curr Opin Organ Transplant. 2009 Jun;14(3):225-30. doi: 10.1097/MOT.0b013e32832b1f32.'}, {'pmid': '18825721', 'type': 'BACKGROUND', 'citation': 'Angus PW, Patterson SJ. Liver transplantation for hepatitis B: what is the best hepatitis B immune globulin/antiviral regimen? Liver Transpl. 2008 Oct;14 Suppl 2:S15-22. doi: 10.1002/lt.21614.'}, {'pmid': '17890261', 'type': 'BACKGROUND', 'citation': 'Riediger C, Berberat PO, Sauer P, Gotthardt D, Weiss KH, Mehrabi A, Merle U, Stremmel W, Encke J. Prophylaxis and treatment of recurrent viral hepatitis after liver transplantation. Nephrol Dial Transplant. 2007 Sep;22 Suppl 8:viii37-viii46. doi: 10.1093/ndt/gfm655.'}, {'pmid': '19852566', 'type': 'BACKGROUND', 'citation': 'Carey I, Harrison PM. Monotherapy versus combination therapy for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2009 Nov;18(11):1655-66. doi: 10.1517/13543780903241599.'}]}, 'descriptionModule': {'briefSummary': 'Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients into the transplant waiting list with HBV-related liver disease.\n2. HBsAg-positive.\n3. serum HBV-DNA negative.\n4. no HCV, HDV and HIV co-infection.\n5. without renal dysfunction.\n6. No lamivudine, adefovir and entecavir drug allergy history.\n7. no HBV-YMDD mutation for patients who have a long-term use of lamivudine.\n\nExclusion Criteria:\n\n1. patients with HBV-related hepatocellular carcinoma beyond Milan criteria.\n2. HBsAg-negative.\n3. serum HBV-DNA positive.\n4. HCV, HDV and HIV co-infection.\n5. patients with severe renal dysfunction or failure.\n6. lamivudine, adefovir and entecavir drug allergy history.\n7. HBV-YMDD mutation for patients who have a long-term use of lamivudine.'}, 'identificationModule': {'nctId': 'NCT01139203', 'briefTitle': 'Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'orgStudyIdInfo': {'id': 'SH20100601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lamivudine', 'interventionNames': ['Drug: lamivudine adefovir entecavir HBIG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lamivudine and adefovir', 'interventionNames': ['Drug: lamivudine adefovir entecavir HBIG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'entecavir', 'interventionNames': ['Drug: lamivudine adefovir entecavir HBIG']}], 'interventions': [{'name': 'lamivudine adefovir entecavir HBIG', 'type': 'DRUG', 'description': 'lamivudine 100mg orally daily adefovir 10mg orally daily entecavir 0.5mg orally daily HBIG 2000 unit intravenously during the anhepatic phase,and followed 800 unit intramuscularly daily until day 14,then 400 unit intramuscularly twice weekly', 'armGroupLabels': ['entecavir', 'lamivudine', 'lamivudine and adefovir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhi-Hai Peng, MD PHD', 'role': 'CONTACT', 'email': 'pengpzh@hotmail.com', 'phone': '0086-021-63240090', 'phoneExt': '3132'}, {'name': 'Tao Li, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhi-Hai Peng, MD PHD', 'role': 'CONTACT', 'email': 'pengpzh@hotmail.com', 'phone': '0086-021-63240090', 'phoneExt': '3132'}, {'name': 'Tao Li, MD', 'role': 'CONTACT', 'email': 'transplant@126.com', 'phone': '0086-021-63240090', 'phoneExt': '3136'}], 'overallOfficials': [{'name': 'Zhi-Hai Peng, MD PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': "Shanghai First People's Hosptial"}}}}