Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-12 @ 10:29 AM
Study NCT ID:
NCT01073202
Status:
COMPLETED
Last Update Posted:
2010-12-30
First Post:
2010-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D002779', 'term': 'Cholestasis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-29', 'studyFirstSubmitDate': '2010-02-22', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2010-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum liver tests', 'timeFrame': 'within the first 4 weeks after liver transplantation', 'description': 'Serum liver tests include serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) and total bilirubin (TB)'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'within the first 4 weeks after liver transplantation', 'description': 'Postoperative complications include rates of acute cellular rejection (ACR), drug-induced hepatotoxicity, vascular or biliary complications, recurrence of primary liver disease and death'}]}, 'conditionsModule': {'conditions': ['Liver Transplantation', 'Ischemia-reperfusion Injury', 'Cholestasis']}, 'referencesModule': {'references': [{'pmid': '10719022', 'type': 'BACKGROUND', 'citation': 'Hertl M, Hertl MC, Kluth D, Broelsch CE. Hydrophilic bile salts protect bile duct epithelium during cold preservation: a scanning electron microscopy study. Liver Transpl. 2000 Mar;6(2):207-12. doi: 10.1002/lt.500060201.'}, {'pmid': '10654358', 'type': 'BACKGROUND', 'citation': 'Hertl M, Hertl MC, Kunkel P, Schilling S, Prevot B, Kluth D, Malago M, Broelsch CE. Tauroursodeoxycholate ameliorates reperfusion injury after pig liver transplantation. Transpl Int. 1999;12(6):454-62. doi: 10.1007/s001470050257.'}, {'pmid': '7705788', 'type': 'BACKGROUND', 'citation': 'Hertl M, Harvey PR, Swanson PE, West DD, Howard TK, Shenoy S, Strasberg SM. Evidence of preservation injury to bile ducts by bile salts in the pig and its prevention by infusions of hydrophilic bile salts. Hepatology. 1995 Apr;21(4):1130-7.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All liver transplant patients in our center between May 2005 and April 2008 were potentially eligible for enrollment\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Treatment with UDCA within one month before operation\n* Inability to provide written informed consent prior to study entry\n* Non-liver organ(s) failure prior to entry'}, 'identificationModule': {'nctId': 'NCT01073202', 'briefTitle': 'Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'orgStudyIdInfo': {'id': 'SFPH05B41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ursodeoxycholic acid', 'interventionNames': ['Drug: ursodeoxycholic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'identical-appearing placebo', 'interventionNames': ['Drug: identical-appearing placebo']}], 'interventions': [{'name': 'ursodeoxycholic acid', 'type': 'DRUG', 'description': '13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation', 'armGroupLabels': ['ursodeoxycholic acid']}, {'name': 'identical-appearing placebo', 'type': 'DRUG', 'description': '13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation', 'armGroupLabels': ['identical-appearing placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhi-Hai Peng, MD', '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'}}}}