Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid

This study has been completed.
Kyoto University
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan Identifier:
First received: May 3, 2007
Last updated: September 13, 2011
Last verified: September 2011
The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver transplantation.

Condition Intervention Phase
Hepatitis C
Liver Cirrhosis
Drug: tacrolimus + steroid
Drug: tacrolimus + mycophenolate mofetil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparative Study on Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparison Between Tacrolimus + MMF and Tacrolimus + Steroid

Resource links provided by NLM:

Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Event-free survival time at the end of first year after living liver transplantation. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection [ Time Frame: 1 year ]

Enrollment: 79
Study Start Date: September 2003
Study Completion Date: August 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug:
tacrolimus + steroid
Drug: tacrolimus + steroid
Active Comparator: 2 Drug:
tacrolimus + mycophenolate mofetil
Drug: tacrolimus + mycophenolate mofetil


Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recipient of living donor liver transplantation for HCV-related cirrhosis

Exclusion Criteria:

  • ABO blood type incompatible transplant case
  • Renal dysfunction (serum creatinine >2.0 mg/dL)
  • WBC < 1,000/mm3
  • Hemoglobin < 8 g/dL
  • Platelet <30,000 /mm3
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00469131

Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Kyoto University
Principal Investigator: Shinji Uemoto, MD, PhD Kyoto University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Shinji Uemoto, M.D. PhD, Professor of Department of Hepatobiliary Pancreatic Surgery and Transplantation, Kyoto University Identifier: NCT00469131     History of Changes
Other Study ID Numbers: UHA-LD-03-01
Study First Received: May 3, 2007
Last Updated: September 13, 2011

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
liver transplantation,
HCV recurrence,

Additional relevant MeSH terms:
Hepatitis C
Liver Cirrhosis
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Disease Attributes
Pathologic Processes
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on May 22, 2017