Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
Recruitment status was Active, not recruiting
The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Randomized, Prospective Multicenter Study To Compare The Efficacy And Safety Among Three Immunosuppressant Treatment Regimens In Patients Receiving A Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection|
- Freedom from acute rejection at 12 months
- Freedom from hepatitis C virus (HCV) recurrence at 12 months
- Freedom from treatment failure at 12 months
- To compare recurrence of HCV by hepatic histology, viral load and allograft biochemistry
- To compare the frequency and severity of biopsy proven rejection
- To compare patient survival and graft survival
- To compare time to first allograft rejection
- To compare time to recurrence of HCV
- To compare maintenance doses of CellCept, Prograf, and corticosteroids and the cumulative doses of corticosteroids and CellCept
|Study Start Date:||July 2002|
End-stage liver disease due to Hepatitis C virus (HCV) infection is the most common reason for liver transplantation in the United States. Patients who have HCV will always carry the virus in their body. If patients respond to treatment, the virus is no longer active. This means that although the virus is still present, it is not currently causing damage to their liver.
Because recurrence of HCV is virtually universal in HCV positive transplant recipients and is associated with long term, possibly lethal complications, the search for the most appropriate therapies must also include methods to prevent or minimize recurrence or disease progression, if the goal of improving long term outcomes for these patients is to be achieved.
Corticosteroids and high doses of immunosuppressive agents have been associated with increased rates of HCV recurrence. Finding a regimen that provides adequate immunosuppression to prevent early and late rejection episodes, and minimizes steroid usage as well as high doses of other immunosuppressive agents is highly desirable.
This study is being conducted to determine the most effective immunosuppressive regimen that will prevent allograft rejection, minimize adverse events and at the same time, prevent or reduce the incidence of HCV recurrence following liver transplant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163657
|United States, Texas|
|Baylor Regional Transplant Institute - Baylor University Medical Center|
|Dallas, Texas, United States, 75246|