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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00286871
First received: February 2, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients who have received liver transplant

Exclusion Criteria:

  • pregnant women
  • nursing women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286871

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

Publications:
ClinicalTrials.gov Identifier: NCT00286871     History of Changes
Other Study ID Numbers: 6538-04-11R0
Study First Received: February 2, 2006
Last Updated: February 2, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014