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

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00469131
• Collaborator: Kyoto University (Other)
• Enrollment: 79
• Location: 1
• Arms: 2
• Duration (Months): 95
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C; Liver Cirrhosis	Drug: tacrolimus + steroid; Drug: tacrolimus + mycophenolate mofetil	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Drug: tacrolimus + steroid	Drug: tacrolimus + steroid
Active Comparator: 2 Drug: tacrolimus + mycophenolate mofetil	Drug: tacrolimus + mycophenolate mofetil

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Kyoto University Hospital	Kyoto		Japan	606-8507

Sponsors and Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Kyoto University

Investigators

• Principal Investigator: Shinji Uemoto, MD, PhD, Kyoto University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00469131
• Other Study ID Numbers: UHA-LD-03-01
• First Posted: May 4, 2007
• Last Update Posted: Sep 14, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by , ,: liver transplantation,; HCV recurrence,; immunosuppression
• Additional relevant MeSH terms: Hepatitis C; Liver Cirrhosis; Recurrence; Mycophenolic Acid; Tacrolimus

Study Results

No Results Posted as of Sep 14, 2011