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.

Verified by Translational Research Informatics Center, Kobe, Hyogo, Japan, February 2009

First Received: May 3, 2007 Last Updated: February 12, 2009 History of Changes

Sponsors and Collaborators:	Translational Research Informatics Center, Kobe, Hyogo, Japan Kyoto University
Information provided by:	Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:	NCT00469131

Purpose

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis C Liver Transplantation

Drug Information available for: Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	September 2003
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Drug:: Active Comparator tacrolimus + steroid	Drug: tacrolimus + steroid
2 Drug:: Active Comparator tacrolimus + mycophenolate mofetil	Drug: tacrolimus + mycophenolate mofetil

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469131

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

Locations

Japan
Kyoto University Hospital	Recruiting
Kyoto, Japan, 606-8507
Contact: Yasutsugu Takada, MD +81-75-751-4323 takaday@kuhp.kyoto-u.ac.jp
Principal Investigator: Yasutsugu Takada, MD

Sponsors and Collaborators

Translational Research Informatics Center, Kobe, Hyogo, Japan

Kyoto University

Investigators

Principal Investigator:

Shinji Uemoto, MD, PhD

Kyoto University

More Information

No publications provided

Responsible Party:	Kyoto University ( Shinji Uemoto, M.D. PhD, Professor of Department of Hepatobiliary Pancreatic Surgery and Transplantation )
Study ID Numbers:	UHA-LD-03-01
Study First Received:	May 3, 2007
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00469131 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

liver taransplantation,
HCV recurrence,
immunosuppression

Study placed in the following topic categories:

Liver Diseases
Immunologic Factors
Fibrosis
Hepatitis, Viral, Human
Liver Cirrhosis
Tacrolimus
Immunosuppressive Agents

Recurrence
Hepatitis
Virus Diseases
Digestive System Diseases
Mycophenolate mofetil
Hepatitis C

Additional relevant MeSH terms:

Liver Diseases
RNA Virus Infections
Disease Attributes
Immunologic Factors
Flaviviridae Infections
Fibrosis
Physiological Effects of Drugs
Hepatitis, Viral, Human
Tacrolimus
Liver Cirrhosis

Immunosuppressive Agents
Pharmacologic Actions
Recurrence
Hepatitis
Virus Diseases
Digestive System Diseases
Pathologic Processes
Mycophenolate mofetil
Hepatitis C

ClinicalTrials.gov processed this record on July 06, 2009