Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT00155194
Status:
UNKNOWN
Last Update Posted:
2005-09-12
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001656', 'term': 'Biliary Atresia'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-06', 'lastUpdateSubmitDate': '2005-09-09', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Biliary Atresia']}, 'descriptionModule': {'briefSummary': 'Null hypothesis of this study: Biliary atresia patients with cholestatic jaundice do not have systemic immunity defect.', 'detailedDescription': 'Biliary atresia patients with cholestatic jaundice were noted to have increased incidence of infectious complications. Previous animal models of bile duct ligation with acute jaundice ever demonstrated impairment of both humoral and cellular immune function. We performed the immunity study in biliary atresia patients due to the lack of comprehensive systemic immunity study in pediatric cholestatic model. Systemic humoral immunity (total serum IgG, IgA, IgM, C3 and C4), specific cellular immunity (lymphocyte classification, mitogen response, cytokines level after PHA stimulation test), and non-specific cellular immunity (absolute neutrophil count, PMN CD11b/CD18 expression level, PMN superoxide release function, and PMN phagocytosis function) were tested. Association with serum bilirubin level, nutritional status and blood biochemical values were tested to see the relation between systemic immune function and cholestatic jaundice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBiliary patients older than 1-year-old status post Kasai operation.\n\nExclusion Criteria:\n\nReceived liver transplantation, immunosuppresant, systemic immunoglobulin (within 6 months) and obvious infectious episode (within 2 weeks).'}, 'identificationModule': {'nctId': 'NCT00155194', 'briefTitle': 'Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Impaired T-Lymphocyte Proliferative Function in Biliary Atresia Children With Prolonged Jaundice', 'orgStudyIdInfo': {'id': '9361701170'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yen-Hsuan Ni, MD', 'role': 'CONTACT', 'email': 'yhni@ha.mc.ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '5451'}, {'name': 'Jia-Feng Wu, MD', 'role': 'CONTACT', 'email': 'water@ha.mc.ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '5451'}, {'name': 'Jia-Feng Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Pediatrics, National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jia-Feng Wu, MD', 'role': 'CONTACT', 'email': 'water@ha.mc.ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '5451'}], 'overallOfficials': [{'name': 'Mei-Hwei Chang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Pediatrics, Natonal Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}}}}