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Completed

NCT Number: NCT00286871

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

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

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Immunosuppression Infections Liver Diseases Organ Transplantation Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients who have received liver transplant

Exclusion criteria

  • pregnant women
  • nursing women

Treatment and study plan

Neoral

Drug

Tacrolimus

Drug

Primary outcomes

  1. compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf

Secondary outcomes

  1. compare the effectiveness of Neoral with Prograf as primary immunotherapy

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

Steroid Avoidance in Hep C OLT

Important dates

Study start
2006
Study completion
2009
First posted
Feb 6, 2006
Registry last updated
Sep 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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