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

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ClinicalTrials.gov Identifier: NCT00163657
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
End Stage Liver Disease Hepatitis C Drug: Daclizumub Drug: Tacrolimus Drug: Cyclosporine Drug: MMF Phase 4

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 If patients respond to treatment, the virus is no longer active.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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2002
Primary Completion Date : April 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: tacrolimus and cyclosporine
immunosuppressant treatment regimens the intervention is antirejection treatment with the above labeled drugs tacrolimus and cyclosporine
Drug: Daclizumub
anti-rejection drug
Other Name: Zenapax
Drug: Tacrolimus
anti rejection drug
Other Name: Prograf
Active Comparator: MMF, tacrolimus and cyclosporine
immunosuppressant treatment regimensthe intervention is antirejection treatment with the above labeled drugs MMF tacrolimus and cyclosporine
Drug: Tacrolimus
anti rejection drug
Other Name: Prograf
Drug: Cyclosporine
anti rejection drug
Other Name: Neoral
Drug: MMF
anti rejection drug
Other Name: mycophenolate mofetil
Active Comparator: daclizumub, MMFand tacrolimus
immunosuppressant treatment regimens
Drug: Daclizumub
anti-rejection drug
Other Name: Zenapax
Drug: Tacrolimus
anti rejection drug
Other Name: Prograf
Drug: MMF
anti rejection drug
Other Name: mycophenolate mofetil

Outcome Measures

Primary Outcome Measures :
  1. Freedom From Acute Rejection or HCV Recurrence or Treatment Failure [ Time Frame: 12 months ]
    Freedom from acute rejection (Banff>grade 2 with RAI score>4) or freedom from HCV recurrence (Batts/Ludwig>Stage 2, or >Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"

  2. Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure [ Time Frame: 12 month post transplant ]
    Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163657

United States, Texas
Baylor Regional Transplant Institute - Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Baylor Health Care System
Emory University
University of Southern California
Mayo Clinic - Scottsdale/Phoenix, Arizona
New York Presbyterian Hospital
Oregon Health and Science University
New York University
University of Cincinnati
University of Alabama at Birmingham
The University of Texas Health Science Center at San Antonio
University of Chicago
University of California, San Francisco
Mayo Clinic - Rochester, Minnesota
Medical University of South Carolina
University of Virginia
Lahey Clinic
University of Medicine and Dentistry of New Jersey
Northwestern Memorial Hospital
Principal Investigator: Goran Klintmalm, MD Baylor Univeristy Medical Center
More Information

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00163657     History of Changes
Other Study ID Numbers: 02-01-L
ZEN159 ( Other Identifier: Baylor Research Institute )
First Posted: September 14, 2005    Key Record Dates
Results First Posted: January 12, 2017
Last Update Posted: January 12, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No their is not a plan to make individual Participant data available

Keywords provided by Baylor Research Institute:
Hepatitis C Virus
Immunosuppressive Agents

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Liver Failure
Hepatic Insufficiency
Immunosuppressive Agents
Mycophenolic Acid
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents