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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286871
First Posted: February 6, 2006
Last Update Posted: September 22, 2014
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.
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Duke University
  Purpose
Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.

Condition Intervention Phase
Chronic Hepatitis C Organ Transplantation Immunosuppression Drug: Neoral Drug: Tacrolimus Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Steroid Avoidance in Hep C OLT

Resource links provided by NLM:


Further study details as provided by Duke University:

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

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

Estimated Enrollment: 40
Study Start Date: February 2006
Estimated Study Completion Date: February 2009
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.
  Eligibility

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
Criteria

Inclusion Criteria:

  • adult patients who have received liver transplant

Exclusion Criteria:

  • pregnant women
  • nursing women
  Contacts and Locations
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): NCT00286871


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Novartis Pharmaceuticals
Investigators
Principal Investigator: Devai Desai, MD, PhD Duke University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00286871     History of Changes
Other Study ID Numbers: 6538
6538-04-11R0 ( Other Identifier: Duke legacy protocol ID )
First Submitted: February 2, 2006
First Posted: February 6, 2006
Last Update Posted: September 22, 2014
Last Verified: February 2006

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action