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

This study has been completed.
Sponsor:
Collaborator:
Kyoto University
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00469131
First received: May 3, 2007
Last updated: September 13, 2011
Last verified: September 2011
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Translational Research Informatics Center, Kobe, Hyogo, Japan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Mycophenolic Acid
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014