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

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, May 2007

Sponsored by:	Translational Research Informatics Center, Kobe, Hyogo, Japan
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

MedlinePlus related topics:

Cirrhosis Hepatitis C

ChemIDplus related topics:

Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	120
Study Start Date:	September 2003
Estimated Study Completion Date:	August 2008

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

Investigators


Principal Investigator:	Yasutsugu Takada, MD, PhD	Kyoto University

More Information

Study ID Numbers:	UHA-LD-03-01
First Received:	May 3, 2007
Last Updated:	May 3, 2007
ClinicalTrials.gov Identifier:	NCT00469131
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:

Communicable Diseases

Liver Diseases

Fibrosis

Hepatitis, Viral, Human

Liver Cirrhosis

Tacrolimus

Infection

Recurrence

Hepatitis

Signs and Symptoms

Pathologic Processes

Mycophenolate mofetil

Hepatitis C

Additional relevant MeSH terms:

Virus Diseases

Disease Attributes

RNA Virus Infections

Digestive System Diseases

Immunologic Factors

Flaviviridae Infections

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Pathological Conditions, Signs and Symptoms

ClinicalTrials.gov processed this record on May 14, 2008