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

NCT ID: NCT00469131

Last Updated: 2011-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Hepatitis C Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Drug:

tacrolimus + steroid

Group Type ACTIVE_COMPARATOR

tacrolimus + steroid

Intervention Type DRUG

2 Drug:

tacrolimus + mycophenolate mofetil

Group Type ACTIVE_COMPARATOR

tacrolimus + mycophenolate mofetil

Intervention Type DRUG

Interventions

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tacrolimus + steroid

Intervention Type DRUG

tacrolimus + mycophenolate mofetil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyoto University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Kyoto University

Principal Investigators

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Shinji Uemoto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyoto University Hospital

Locations

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Kyoto University Hospital

Kyoto, Kyoto, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 23696054 (View on PubMed)

Other Identifiers

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UHA-LD-03-01

Identifier Type: -

Identifier Source: org_study_id

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