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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01073202
First Posted: February 23, 2010
Last Update Posted: December 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shanghai Jiao Tong University School of Medicine
  Purpose
This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.

Condition Intervention
Liver Transplantation Ischemia-reperfusion Injury Cholestasis Drug: ursodeoxycholic acid Drug: identical-appearing placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 112
Study Start Date: May 2005
Study Completion Date: January 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01073202     History of Changes
Other Study ID Numbers: SFPH05B41
First Submitted: February 22, 2010
First Posted: February 23, 2010
Last Update Posted: December 30, 2010
Last Verified: December 2009

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Cholestasis
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents