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

This study is currently recruiting participants.
Information provided by Translational Research Informatics Center, Kobe, Hyogo, Japan

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Descriptive Information Fields
Brief Title † Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid
Official Title † Randomized Comparative Study on Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparison Between Tacrolimus + MMF and Tacrolimus + Steroid
Brief Summary

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.
Detailed Description
Study Phase Phase III
Study Type † Interventional
Study Design † Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure † Event-free survival time at the end of first year after living liver transplantation. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure † 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 ] [ Designated as safety issue: Yes ]
Condition † Hepatitis C
Liver Cirrhosis
Intervention † Drug: tacrolimus + steroid
Drug: tacrolimus + mycophenolate mofetil
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 120
Start Date † September 2003
Completion Date August 2011
Eligibility Criteria †

Inclusion Criteria:

  • Recipient of living donor liver trasnplantation 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
Gender Both
Ages 18 Years to 69 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Yasutsugu Takada, MD, PhD     +81-75-751-4323     takaday@kuhp.kyoto-u.ac.jp    
Contact: Toshimi Kaido, MD, PhD     +81-75-751-4323     kaido@kuhp.kyoto-u.ac.jp    
Location Countries † Japan
Administrative Information Fields
NCT ID † NCT00469131
Organization ID UHA-LD-03-01
Secondary IDs ††
Study Sponsor † Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborators †† Kyoto University
Investigators †
Principal Investigator:     Shinji Uemoto, MD, PhD     Kyoto University    
Information Provided By Translational Research Informatics Center, Kobe, Hyogo, Japan
Verification Date December 2007
First Received Date † May 3, 2007
Last Updated Date June 9, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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