Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection

Completed · Phase 4

Conditions studied: End Stage Liver Disease, Hepatitis C

In brief

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.

Key facts

Study ID

NCT00163657

Run by

Baylor Research Institute

People needed

312

Starts

2002-07-01

Expected to finish

2007-01-01

Last updated by the study team

2017-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baylor Regional Transplant Institute - Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.