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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Collaborators: Baylor Health Care System; Baylor University; Emory University; Lahey Clinic; Mayo Clinic; Mayo Clinic - Rochester, Minnesota; Mayo Clinic - Scottsdale/Phoenix, Arizona; Medical University of South Carolina; New York Presbyterian Hospital; New York University; Northwestern Memorial Hospital; Oregon Health and Science University; The University of Texas Health Science Center at San Antonio; 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
• Treatments: Cyclosporine; Cyclosporins; Daclizumab; Mycophenolic Acid; Tacrolimus

Criteria

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 (blood group anti A, anti B antibodies) 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 (TAC), HCO-60, CellCept (MMF), 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.