Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-22 @ 4:15 PM
Study NCT ID:
NCT03865966
Status:
RECRUITING
Last Update Posted:
2019-07-08
First Post:
2019-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatitis B Virus Infection After Liver Transplantation in Children
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood and liver tissue specimens。'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-04', 'studyFirstSubmitDate': '2019-03-04', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of occult hepatitis b virus infection', 'timeFrame': '3-5 years', 'description': 'Clinical follow-up testing for occult HBV infection after liver transplantation in children'}, {'measure': 'The rate of overt hepatitis b virus infection', 'timeFrame': '3-5 years', 'description': 'Clinical follow-up testing for overt HBV infection after liver transplantation in children'}], 'secondaryOutcomes': [{'measure': 'The levels and changes of anti-HBs after liver transplantation', 'timeFrame': '3-5 years', 'description': 'Clinical follow-up testing for HBV seromarkers after liver transplantation in children'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B Infection']}, 'descriptionModule': {'briefSummary': "China is a highly prevalent area of hepatitis B virus（HBV） infection, with at least 75 million hepatitis B virus carriers, and 80% of primary hepatocellular carcinoma (HCC) is associated with chronic hepatitis B virus infection. Liver transplantation is currently the preferred method for end-stage liver disease such as biliary atresia and cirrhosis in children. In recent years, children's liver transplantation has developed rapidly and the number of developments has increased significantly. If there is chronic hepatitis B virus infection in the donor liver, it may cause HBV transmission, or the patient may have a low-load occult hepatitis B virus infection, and after immunosuppressive treatment, it may lead to hepatitis B virus infection after surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'End-stage liver disease requires liver transplantation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with end-stage liver disease who require liver transplantation\n\nExclusion Criteria:\n\n* Children without liver transplantation refer to children;\n* Children who are unwilling to participate;'}, 'identificationModule': {'nctId': 'NCT03865966', 'briefTitle': 'Hepatitis B Virus Infection After Liver Transplantation in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Chongqing Medical University"}, 'officialTitle': 'Clinical Follow-up Study on Hepatitis B Virus Infection After Liver Transplantation in Children', 'orgStudyIdInfo': {'id': '2019-24'}}, 'armsInterventionsModule': {'interventions': [{'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400014', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yao Zhao', 'role': 'CONTACT'}], 'facility': "Chongqing Children's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Yao Zhao', 'role': 'CONTACT', 'email': 'Zhaoy@cqmu.edu.cn', 'phone': '+862363603083'}], 'overallOfficials': [{'name': 'Yao Zhao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Chongqing Children's Hospital of Chongqing Medical University"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '3-5 years', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qiu Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Qiu Li', 'investigatorAffiliation': "Children's Hospital of Chongqing Medical University"}}}}