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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469131
• Other study ID #: UHA-LD-03-01
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2007
• Last updated: September 13, 2011
• Start date: September 2003
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Liver Cirrhosis
• Recurrence

Intervention

Drug:
• tacrolimus + steroid

• tacrolimus + mycophenolate mofetil

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Kyoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival time at the end of first year after living liver transplantation.		1 year	Yes
Secondary	HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection		1 year	Yes