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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase: Completed; Phase 3

Conditions: Hepatitis C; Liver Cirrhosis

Treatments: Drug: tacrolimus + steroid; Drug: tacrolimus + mycophenolate mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT00469131

UHA-LD-03-01

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

1 Drug:

Active Comparator group

Description:

tacrolimus + steroid

Treatment:

Drug: tacrolimus + steroid

2 Drug:

Active Comparator group

Description:

tacrolimus + mycophenolate mofetil

Treatment:

Drug: tacrolimus + mycophenolate mofetil