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

Primary Purpose

Hepatitis C, Liver Cirrhosis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
tacrolimus + steroid
tacrolimus + mycophenolate mofetil
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring liver transplantation,, HCV recurrence,, immunosuppression

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kyoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 Drug:

2 Drug:

Arm Description

tacrolimus + steroid

tacrolimus + mycophenolate mofetil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection

Full Information

First Posted
May 3, 2007
Last Updated
September 13, 2011
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Kyoto University
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1. Study Identification

Unique Protocol Identification Number
NCT00469131
Brief Title
Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid
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 Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Kyoto University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Liver Cirrhosis
Keywords
liver transplantation,, HCV recurrence,, immunosuppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Drug:
Arm Type
Active Comparator
Arm Description
tacrolimus + steroid
Arm Title
2 Drug:
Arm Type
Active Comparator
Arm Description
tacrolimus + mycophenolate mofetil
Intervention Type
Drug
Intervention Name(s)
tacrolimus + steroid
Intervention Type
Drug
Intervention Name(s)
tacrolimus + mycophenolate mofetil
Primary Outcome Measure Information:
Title
Event-free survival time at the end of first year after living liver transplantation.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinji Uemoto, MD, PhD
Organizational Affiliation
Kyoto University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23696054
Citation
Takada Y, Kaido T, Asonuma K, Sakurai H, Kubo S, Kiuchi T, Inomata Y, Isaji S, Tsumura H, Teramukai S, Matsubara Y, Sakabayashi S, Uemoto S. Randomized, multicenter trial comparing tacrolimus plus mycophenolate mofetil to tacrolimus plus steroids in hepatitis C virus-positive recipients of living donor liver transplantation. Liver Transpl. 2013 Aug;19(8):896-906. doi: 10.1002/lt.23679.
Results Reference
derived

Learn more about this trial

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

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