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

Tracking Information

First Received Date ^ICMJE

May 3, 2007

Last Updated Date

February 12, 2009

Start Date ^ICMJE

September 2003

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Event-free survival time at the end of first year after living liver transplantation. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00469131 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hepatitis C
Liver Cirrhosis

Intervention ^ICMJE

Drug: tacrolimus + steroid
Drug: tacrolimus + mycophenolate mofetil

Study Arms / Comparison Groups

Active Comparator: tacrolimus + steroid
Active Comparator: tacrolimus + mycophenolate mofetil

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

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 ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00469131

Responsible Party

Shinji Uemoto, M.D. PhD, Professor of Department of Hepatobiliary Pancreatic Surgery and Transplantation, Kyoto University

Study ID Numbers ^ICMJE

UHA-LD-03-01

Study Sponsor ^ICMJE

Translational Research Informatics Center, Kobe, Hyogo, Japan

Collaborators ^ICMJE

Kyoto University

Investigators ^ICMJE

Principal Investigator:

Shinji Uemoto, MD, PhD

Kyoto University

Information Provided By

Translational Research Informatics Center, Kobe, Hyogo, Japan

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP