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

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

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Key information

Conditions

Liver Transplantation Bile Duct Diseases Biliary Tract Diseases Cardiovascular Diseases Cholestasis Digestive System Diseases Ischemia-Reperfusion Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ursodeoxycholic acid

Drug

13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation

Identical-appearing Placebo

Drug

13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation

Primary outcomes

Serum liver tests

Time frame: within the first 4 weeks after liver transplantation

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 outcomes

Postoperative complications

Time frame: within the first 4 weeks after liver transplantation

Postoperative complications include rates of acute cellular rejection (ACR), drug-induced hepatotoxicity, vascular or biliary complications, recurrence of primary liver disease and death

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2009
First posted: Feb 23, 2010
Registry last updated: Dec 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed