Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid
Phase 3
Completed
- Conditions
- Hepatitis CLiver Cirrhosis
- Interventions
- Registration Number
- NCT00469131
- Lead Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Drug: tacrolimus + steroid tacrolimus + steroid 2 Drug: tacrolimus + mycophenolate mofetil tacrolimus + mycophenolate mofetil
- Primary Outcome Measures
Name Time Method Event-free survival time at the end of first year after living liver transplantation. 1 year
- Secondary Outcome Measures
Name Time Method HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection 1 year
Trial Locations
- Locations (1)
Kyoto University Hospital
🇯🇵Kyoto, Japan