Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation

Liver Transplantation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073202
• Other study ID #: SFPH05B41
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: December 29, 2010
• Start date: May 2005
• Est. completion date: January 2009

Study information

• Verified date: December 2009
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis
• Ischemia-reperfusion Injury
• Liver Transplantation
• Reperfusion Injury

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Shanghai First People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View Citation

Hertl M, Hertl MC, Kunkel P, Schilling S, Prevot B, Kluth D, Malagó M, Broelsch CE. Tauroursodeoxycholate ameliorates reperfusion injury after pig liver transplantation. Transpl Int. 1999;12(6):454-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	within the first 4 weeks after liver transplantation	No
Secondary	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	within the first 4 weeks after liver transplantation	Yes