Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation
NCT ID: NCT01073202
Last Updated: 2010-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2005-05-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ursodeoxycholic acid
ursodeoxycholic acid
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
identical-appearing placebo
identical-appearing placebo
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
Interventions
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ursodeoxycholic acid
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
identical-appearing placebo
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Treatment with UDCA within one month before operation
* Inability to provide written informed consent prior to study entry
* Non-liver organ(s) failure prior to entry
18 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Principal Investigators
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Zhi-Hai Peng, MD
Role: STUDY_CHAIR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
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.
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.
Other Identifiers
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SFPH05B41
Identifier Type: -
Identifier Source: org_study_id