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Trial record 37 of 66 for:    "Viral Infectious Disease" | "Mycophenolic acid"

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

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ClinicalTrials.gov Identifier: NCT00469131
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : September 14, 2011
Sponsor:
Collaborator:
Kyoto University
Information provided by:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Liver Cirrhosis Drug: tacrolimus + steroid Drug: tacrolimus + mycophenolate mofetil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2003
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1 Drug:
tacrolimus + steroid
Drug: tacrolimus + steroid
Active Comparator: 2 Drug:
tacrolimus + mycophenolate mofetil
Drug: tacrolimus + mycophenolate mofetil



Primary Outcome Measures :
  1. Event-free survival time at the end of first year after living liver transplantation. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469131


Locations
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Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Kyoto University
Investigators
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Principal Investigator: Shinji Uemoto, MD, PhD Kyoto University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shinji Uemoto, M.D. PhD, Professor of Department of Hepatobiliary Pancreatic Surgery and Transplantation, Kyoto University
ClinicalTrials.gov Identifier: NCT00469131     History of Changes
Other Study ID Numbers: UHA-LD-03-01
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011
Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
liver transplantation,
HCV recurrence,
immunosuppression
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Mycophenolic Acid
Hepatitis C
Liver Cirrhosis
Recurrence
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Pathologic Processes
Disease Attributes
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents