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Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00286871
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : September 22, 2014
Novartis Pharmaceuticals
Information provided by:
Duke University

Tracking Information
First Submitted Date  ICMJE February 2, 2006
First Posted Date  ICMJE February 6, 2006
Last Update Posted Date September 22, 2014
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00286871 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
compare the effectiveness of Neoral with Prograf as primary immunotherapy
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 Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen
Official Title  ICMJE Steroid Avoidance in Hep C OLT
Brief Summary Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.
Detailed Description Recurrent HCV in the liver allograft is becoming the leading indicator for retransplantation. Studies suggest that glucocorticord-based immunosuppression regimens hasten the onset and progression of recurrent chronic HCV liver disease. Treatment of acute allograft rejection with steroid boluses is also associated with rapid HCV recurrence. The relative contribution of various calcineurin inhibitors to recurrent HCV liver disease has not been established. Previous retrospective studies, as well as prospective studies have not demonstrated a difference in recurrent HCV liver disease rates between patients receiving CsA or tacrolimus immunosuppression regimens respectively.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Hepatitis C
  • Organ Transplantation
  • Immunosuppression
Intervention  ICMJE
  • Drug: Neoral
  • Drug: Tacrolimus
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: February 2, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients who have received liver transplant

Exclusion Criteria:

  • pregnant women
  • nursing women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00286871
Other Study ID Numbers  ICMJE 6538
6538-04-11R0 ( Other Identifier: Duke legacy protocol ID )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Devai Desai, MD, PhD Duke University
PRS Account Duke University
Verification Date February 2006

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