Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection (NCT00163657) | Clinical Trial Compass
CompletedPhase 4
Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
United States312 participantsStarted 2002-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Freedom From Acute Rejection or HCV Recurrence or Treatment Failure
Timeframe: 12 months
2
Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure
✕. 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.