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

This study has been completed.

First Received on May 3, 2007. Last Updated on September 13, 2011 History of Changes

Sponsor:	Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborator:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis A 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 ]

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

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 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

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

Locations

Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507

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:	Shinji Uemoto, M.D. PhD, Professor of Department of Hepatobiliary Pancreatic Surgery and Transplantation, Kyoto University
ClinicalTrials.gov Identifier:	NCT00469131 History of Changes
Other Study ID Numbers:	UHA-LD-03-01
Study First Received:	May 3, 2007
Last Updated:	September 13, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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

liver transplantation,
HCV recurrence,
immunosuppression

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Liver Cirrhosis
Fibrosis
Recurrence
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

Pathologic Processes
Disease Attributes
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012