NCT00469131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 14, 2011

Status Verified

September 1, 2011

Enrollment Period

6.9 years

First QC Date

May 3, 2007

Last Update Submit

September 13, 2011

Conditions

Hepatitis CLiver Cirrhosis

Keywords

liver transplantation,HCV recurrence,immunosuppression

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (1)

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

    1 year

Study Arms (2)

1 Drug:

ACTIVE COMPARATOR

tacrolimus + steroid

Drug: tacrolimus + steroid

2 Drug:

ACTIVE COMPARATOR

tacrolimus + mycophenolate mofetil

Drug: tacrolimus + mycophenolate mofetil

Interventions

tacrolimus + steroidDRUG
1 Drug:
tacrolimus + mycophenolate mofetilDRUG
2 Drug:

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipient of living donor liver transplantation for HCV-related cirrhosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23696054DERIVED

MeSH Terms

Conditions

Hepatitis CLiver Cirrhosis

Interventions

TacrolimusSteroidsMycophenolic Acid

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsFused-Ring CompoundsPolycyclic CompoundsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Shinji Uemoto, MD, PhD

    Kyoto University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 4, 2007

Study Start

September 1, 2003

Primary Completion

August 1, 2010

Study Completion

August 1, 2011

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations

JP(1)