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

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ClinicalTrials.gov Identifier: NCT01073202
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : December 30, 2010
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine

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

Condition or disease Intervention/treatment Phase
Liver Transplantation Ischemia-reperfusion Injury Cholestasis Drug: ursodeoxycholic acid Drug: identical-appearing placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ursodiol

Arm Intervention/treatment
Active Comparator: ursodeoxycholic acid Drug: ursodeoxycholic acid
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation

Placebo Comparator: identical-appearing placebo Drug: identical-appearing placebo
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073202


Locations
China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Chair: Zhi-Hai Peng, MD Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine