TITLE: REFINE: Randomized evaluation of fibrosis due to hepatitis C after de novo liver transplant; a multicenter, randomized, open label study to compare the development of liver fibrosis at 12 months after transplantation for hepatitis C cirrhosis in patients receiving either Neoral or tacrolimus (COLO400A2426)

Why is this study being done? 
All patients who have had a liver transplant need to take drugs so that their body will not reject the new liver. Some drugs have different effects than others and this study will attempt to discern if giving Neoral® instead of tacrolimus will delay the onset of liver fibrosis or scarring in the new liver.

Cirrhosis is the destruction of normal liver tissue that leaves scar tissue that does not function around areas of normal liver tissue. The scar tissue (or fibrosis) that forms impairs the liver's ability to function and obstructs the flow of blood through the portal vein (the vein that carries blood from the intestines to the liver). After a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes scarring leading to cirrhosis of the new liver. The aim of this study is to see if the time to return of liver scarring is longer with Neoral® than tacrolimus.

Who is eligible to participate in this study?

Minimum Age: 18
Maximum Age: 70

What is Involved With this Study? 

This study will compare two drugs called Neoral® (cyclosporine, modified) and Prograf® (tacrolimus), either of which can be given so that your body will not reject the new liver. Both Neoral and Prograf are approved by the Food and Drug Administration (FDA). Patients will be randomized to receive either Neoral or Prograf during the 24 months of the study. There are 12 study visits during the 12 month study period and one final visit twelve months after the end of the study (that is, at 24 months after liver transplant).