Orthotopic Liver Transplant (OLT) Recipients With Hepatitis C Virus (HCV) Under Preemptive Treatment
Status:
Withdrawn
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
After a liver transplant, the hepatitis C virus (which destroyed one's own liver) eventually
comes back. In many patients, this will eventually cause the loss of the new liver and can
also confuse the doctors taking care of them because it is hard to tell the difference
between one's body rejecting the new liver and hepatitis. This can cause serious treatment
errors that can lead to more severe hepatitis or to rejection of the liver. Some of the drugs
used to prevent rejection of one's new liver can cause the hepatitis to come back in a more
severe form. This is especially true for the drugs known as corticosteroids.
Right now, the only effective treatment against hepatitis C is a combination of two drugs
called interferon and ribavirin. These drugs act by strengthening one's immune system to
fight the virus and by directly reducing the reproduction of the virus. Because the treatment
with these drugs is associated with many side effects, there is little experience with
treating patients after liver transplantation with them.
In the investigators' transplant program, they have decided to treat all patients with
hepatitis C as early as possible after transplantation and to follow them closely for the
development of hepatitis and side effects of the treatment. The investigators treat one's
hepatitis as early as possible, before any actual damage has occurred in the new liver. This
approach has been tried before but it has been hard to tell if it has worked or not. The main
reason for failure was that many patients could not complete the treatment due to side
effects. The investigators' purpose is to treat those side effects aggressively so that most
patients can complete the treatment course.
The purpose of this study is to collect all the data regarding the investigators' treatment
protocol so that they will be able to learn if this form of treatment is beneficial.
The study includes performing liver biopsies at scheduled times after one's liver transplant
and for scheduled blood tests to see how much virus is still in the blood. If patients show
signs that they are not responding to treatment they will be removed from the study.
Phase:
Phase 4
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston