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

This study has been completed.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01073202
First received: February 22, 2010
Last updated: December 29, 2010
Last verified: December 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Ursodiol
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 First People's Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT01073202     History of Changes
Other Study ID Numbers: SFPH05B41
Study First Received: February 22, 2010
Last Updated: December 29, 2010
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013