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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00469131

Enrollment

Registered

2007-05-04

Start date

2003-09-30

Completion date

2011-08-31

Last updated

2011-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Liver Cirrhosis

Keywords

liver transplantation,, HCV recurrence,, immunosuppression

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.

Interventions

DRUGtacrolimus + steroid

DRUGtacrolimus + mycophenolate mofetil

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Event-free survival time at the end of first year after living liver transplantation.	1 year

Secondary

Measure	Time frame
HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection	1 year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026