Overview

This trial is active, not recruiting.

Condition liver transplantation
Treatment daclizumab
Phase phase 4
Sponsor Baylor Research Institute
Collaborator Baylor University
Start date July 2002
Trial size 312 participants
Trial identifier NCT00163657, 02-01-L, ZEN159

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Freedom from acute rejection at 12 months
time frame:
Freedom from hepatitis C virus (HCV) recurrence at 12 months
time frame:
Freedom from treatment failure at 12 months
time frame:

Secondary Outcomes

Measure
To compare recurrence of HCV by hepatic histology, viral load and allograft biochemistry
time frame:
To compare the frequency and severity of biopsy proven rejection
time frame:
To compare patient survival and graft survival
time frame:
To compare time to first allograft rejection
time frame:
To compare time to recurrence of HCV
time frame:
To compare maintenance doses of CellCept, Prograf, and corticosteroids and the cumulative doses of corticosteroids and CellCept
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. 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. 2. Patient is a recipient of a primary whole/split, cadaveric/living donor liver transplant for end stage chronic Hepatitis C. 3. Patient is > age 18. 4. 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: 1. Patient has previously received or is receiving an organ transplant other than a liver. 2. Patient has received a liver transplant from a Hepatitis B core antibody or a Hepatitis C antibody positive donor. 3. Patient has received an ABO incompatible donor liver. 4. 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). 5. 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. 6. 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. 7. Recipient or donor is seropositive for human immunodeficiency virus (HIV) or HbsAg positive serology. 8. Patient is to receive antilymphocyte antibody induction therapy, such as ATGAM (lymphocyte immune globulin), OKT3 (muromonab-CD3), Simulect (basiliximab), or Thymoglobulin. 9. Patient has a known hypersensitivity to Prograf, HCO-60, CellCept, Zenapax or corticosteroids. 10. Patient is pregnant or lactating. 11. Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment. 12. 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.

Additional Information

Official title An Open-Label, Randomized, Prospective Multicenter Study To Compare The Efficacy And Safety Among Three Immunosuppressant Treatment Regimens In Patients Receiving A Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
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 body. If patients respond to treatment, the virus is no longer active. This means that although the virus is still present, it is not currently causing damage to their liver. Because recurrence of HCV is virtually universal in HCV positive transplant recipients and is associated with long term, possibly lethal complications, the search for the most appropriate therapies must also include methods to prevent or minimize recurrence or disease progression, if the goal of improving long term outcomes for these patients is to be achieved. Corticosteroids and high doses of immunosuppressive agents have been associated with increased rates of HCV recurrence. Finding a regimen that provides adequate immunosuppression to prevent early and late rejection episodes, and minimizes steroid usage as well as high doses of other immunosuppressive agents is highly desirable. This study is being conducted to determine the most effective immunosuppressive regimen that will prevent allograft rejection, minimize adverse events and at the same time, prevent or reduce the incidence of HCV recurrence following liver transplant.
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Baylor Research Institute.