Clinical trial NCT00163657: Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
Official title: An Open-Label, Randomized, Prospective Multicenter Study To Compare The Efficacy And Safety Among 3 Immunosuppressant Treatment Regimens In Patients Receiving A Liver Transplant For ESLD Caused By Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Liver Disease
Hepatitis C
Keywords: Hepatitis C Virus
Immunosuppressive Agents
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Baylor Health Care System
name: Emory University
name: University of Southern California
name: Mayo Clinic - Scottsdale/Phoenix, Arizona
name: New York Presbyterian Hospital
name: Oregon Health and Science University
name: New York University
name: University of Cincinnati
name: University of Alabama at Birmingham
name: The University of Texas Health Science Center at San Antonio
name: University of Chicago
name: University of California, San Francisco
name: Mayo Clinic - Rochester, Minnesota
name: Medical University of South Carolina
name: University of Virginia
name: Lahey Clinic
name: University of Medicine and Dentistry of New Jersey
name: Northwestern Memorial Hospital
First posted: 2005-09-14
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 If patients respond to treatment, the virus is no longer active.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

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.

Primary outcomes:
measure: Freedom From Acute Rejection or HCV Recurrence or Treatment Failure
timeFrame: 12 months
measure: Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure
timeFrame: 12 month post transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Regional Transplant Institute - Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Univeristy Medical Center
name: Goran Klintmalm, MD
role: PRINCIPAL_INVESTIGATOR
References: