Status:
COMPLETED
Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
Baylor Health Care System
Emory University
Conditions:
End Stage Liver Disease
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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 bo...
Eligibility Criteria
Inclusion
- Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 2 years.
- Patient is a recipient of a primary whole/split, cadaveric/living donor liver transplant for end stage chronic Hepatitis C.
- Patient is \> age 18.
- Female patients of child bearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion.
Exclusion
- Patient has previously received or is receiving an organ transplant other than a liver.
- Patient has received a liver transplant from a Hepatitis B core antibody or a Hepatitis C antibody positive donor.
- Patient has received an ABO (blood group anti A, anti B antibodies) incompatible donor liver.
- Patient has fulminant liver failure with a life expectancy without a liver transplant of less than 7 days as defined by UNOS (Adult Patient Status 1, UNOS Policy 3.6.4.1: See Appendix C).
- Patient has renal dysfunction pre-transplant that, in the opinion of the investigator, will prohibit the use of calcineurin inhibitors within 72 hours post transplant.
- Patient is intubated, on vasopressors, is ICU bound, or has experienced a significant blood loss (greater than 5 units) 72 hours prior to transplant procedure.
- Recipient or donor is seropositive for human immunodeficiency virus (HIV) or HbsAg positive serology.
- Patient is to receive antilymphocyte antibody induction therapy, such as ATGAM (lymphocyte immune globulin), OKT3 (muromonab-CD3), Simulect (basiliximab), or Thymoglobulin.
- Patient has a known hypersensitivity to Prograf (TAC), HCO-60, CellCept (MMF), Zenapax or corticosteroids.
- Patient is pregnant or lactating.
- Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment.
- Patient has participated in a trial involving a market drug within 30 days. However, patients who participated in any interferon or ribavirin trials are permitted.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT00163657
Start Date
July 1 2002
End Date
January 1 2007
Last Update
January 12 2017
Active Locations (1)
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1
Baylor Regional Transplant Institute - Baylor University Medical Center
Dallas, Texas, United States, 75246