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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

Tracking Information
First Submitted Date  ICMJE May 3, 2007
First Posted Date  ICMJE May 4, 2007
Last Update Posted Date September 14, 2011
Study Start Date  ICMJE September 2003
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
Event-free survival time at the end of first year after living liver transplantation. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00469131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid
Official Title  ICMJE Randomized Comparative Study on Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparison Between Tacrolimus + MMF and Tacrolimus + Steroid
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • Liver Cirrhosis
Intervention  ICMJE
  • Drug: tacrolimus + steroid
  • Drug: tacrolimus + mycophenolate mofetil
Study Arms  ICMJE
  • Active Comparator: 1 Drug:
    tacrolimus + steroid
    Intervention: Drug: tacrolimus + steroid
  • Active Comparator: 2 Drug:
    tacrolimus + mycophenolate mofetil
    Intervention: Drug: tacrolimus + mycophenolate mofetil
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2011)
79
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2007)
120
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00469131
Other Study ID Numbers  ICMJE UHA-LD-03-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shinji Uemoto, M.D. PhD, Professor of Department of Hepatobiliary Pancreatic Surgery and Transplantation, Kyoto University
Study Sponsor  ICMJE Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators  ICMJE Kyoto University
Investigators  ICMJE
Principal Investigator: Shinji Uemoto, MD, PhD Kyoto University
PRS Account Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP