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Sponsors and Collaborators: |
Baylor Research Institute Baylor University Emory University University of Southern California Mayo Clinic New York Presbyterian Hospital Oregon Health and Science University New York University School of Medicine University of Cincinnati University of Alabama at Birmingham University of Texas University of Chicago University of California, San Francisco Medical University of South Carolina University of Virginia Lahey Clinic University of Medicine and Dentistry New Jersey Northwestern Memorial Hospital |
Information provided by: | Baylor Research Institute |
ClinicalTrials.gov Identifier: | NCT00163657 |
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.
Condition | Intervention | Phase |
Liver Transplantation |
Drug: Daclizumab |
Phase IV |
MedlinePlus related topics: | Hepatitis Hepatitis C Liver Diseases Liver Transplantation |
ChemIDplus related topics: | Dacliximab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 312 |
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 If patients respond to treatment, the virus is no longer active.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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |||||
Baylor Regional Transplant Institute - Baylor University Medical Center | |||||
Dallas, Texas, United States, 75246 |
Baylor Research Institute |
Baylor University |
Emory University |
University of Southern California |
Mayo Clinic |
New York Presbyterian Hospital |
Oregon Health and Science University |
New York University School of Medicine |
University of Cincinnati |
University of Alabama at Birmingham |
University of Texas |
University of Chicago |
University of California, San Francisco |
Medical University of South Carolina |
University of Virginia |
Lahey Clinic |
University of Medicine and Dentistry New Jersey |
Northwestern Memorial Hospital |
Study ID Numbers: | 02-01-L, ZEN159 |
First Received: | September 9, 2005 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00163657 |
Health Authority: | United States: Food and Drug Administration |
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