Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation
Primary Purpose
Liver Transplantation, Ischemia-reperfusion Injury, Cholestasis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ursodeoxycholic acid
identical-appearing placebo
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplantation
Eligibility Criteria
Inclusion Criteria:
- All liver transplant patients in our center between May 2005 and April 2008 were potentially eligible for enrollment
Exclusion Criteria:
- Age less than 18 years
- 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
Sites / Locations
- Shanghai First People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ursodeoxycholic acid
identical-appearing placebo
Arm Description
Outcomes
Primary Outcome Measures
Serum liver tests
Serum liver tests include serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) and total bilirubin (TB)
Secondary Outcome Measures
Postoperative complications
Postoperative complications include rates of acute cellular rejection (ACR), drug-induced hepatotoxicity, vascular or biliary complications, recurrence of primary liver disease and death
Full Information
NCT ID
NCT01073202
First Posted
February 22, 2010
Last Updated
December 29, 2010
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01073202
Brief Title
Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
5. Study Description
Brief Summary
This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Ischemia-reperfusion Injury, Cholestasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ursodeoxycholic acid
Arm Type
Active Comparator
Arm Title
identical-appearing placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ursodeoxycholic acid
Intervention Description
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
Intervention Type
Drug
Intervention Name(s)
identical-appearing placebo
Intervention Description
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
Primary Outcome Measure Information:
Title
Serum liver tests
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)
Time Frame
within the first 4 weeks after liver transplantation
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Postoperative complications include rates of acute cellular rejection (ACR), drug-induced hepatotoxicity, vascular or biliary complications, recurrence of primary liver disease and death
Time Frame
within the first 4 weeks after liver transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All liver transplant patients in our center between May 2005 and April 2008 were potentially eligible for enrollment
Exclusion Criteria:
Age less than 18 years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Hai Peng, MD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
10719022
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.
Results Reference
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PubMed Identifier
10654358
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.
Results Reference
background
PubMed Identifier
7705788
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.
Results Reference
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Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation
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