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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

Brief Summary:
Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Organ Transplantation Immunosuppression Drug: Neoral Drug: Tacrolimus Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Steroid Avoidance in Hep C OLT
Study Start Date : February 2006
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Primary Outcome Measures :
  1. compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf

Secondary Outcome Measures :
  1. compare the effectiveness of Neoral with Prograf as primary immunotherapy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients who have received liver transplant

Exclusion Criteria:

  • pregnant women
  • nursing women

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 identifier (NCT number): NCT00286871

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Novartis Pharmaceuticals
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Principal Investigator: Devai Desai, MD, PhD Duke University
Layout table for additonal information Identifier: NCT00286871    
Other Study ID Numbers: 6538
6538-04-11R0 ( Other Identifier: Duke legacy protocol ID )
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: February 2006
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action