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

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00163657
• Other study ID #: 02-01-L
• Secondary ID: ZEN159
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: October 14, 2009
• Start date: July 2002

Study information

• Verified date: October 2009
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 If patients respond to treatment, the virus is no longer active.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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 312
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Liver Disease
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Diseases
• Liver Transplantation

Intervention

Drug:
• Daclizumab

Locations

Country	Name	City	State
United States	Baylor Regional Transplant Institute - Baylor University Medical Center	Dallas	Texas

Sponsors (18)

Lead Sponsor

Collaborator

Baylor Research Institute

Baylor University, Emory University, Lahey Clinic, Mayo Clinic, Medical University of South Carolina, New York Presbyterian Hospital, New York University, Northwestern Memorial Hospital, Oregon Health and Science University, University of Alabama at Birmingham, University of California, San Francisco, University of Chicago, University of Cincinnati, University of Medicine and Dentistry of New Jersey, University of Southern California, University of Texas, University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from acute rejection at 12 months
Primary	Freedom from hepatitis C virus (HCV) recurrence at 12 months
Primary	Freedom from treatment failure at 12 months
Secondary	To compare recurrence of HCV by hepatic histology, viral load and allograft biochemistry
Secondary	To compare the frequency and severity of biopsy proven rejection
Secondary	To compare patient survival and graft survival
Secondary	To compare time to first allograft rejection
Secondary	To compare time to recurrence of HCV
Secondary	To compare maintenance doses of CellCept, Prograf, and corticosteroids and the cumulative doses of corticosteroids and CellCept