Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
Condition: End Stage Liver Disease; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Diseases; End Stage Liver Disease
Intervention: Daclizumub; Tacrolimus; Cyclosporine; MMF
Intervention description: anti-rejection drug; anti rejection drug; anti rejection drug; anti rejection drug
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus; Immunosuppressive Agents

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.
    

Eligibility 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.