Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation

This study has been completed.
Information provided by (Responsible Party):
University of Alberta Identifier:
First received: July 2, 2008
Last updated: September 14, 2011
Last verified: September 2011
The purpose of this study is to learn about how different immunosuppressant therapies impact on recurrent hepatitis C virus infection in the new liver after liver transplant. We will be evaluating if Cyclosporin A has a superior effect against recurrent Hepatitis C virus (HCV) infection than Tacrolimus.

Hepatitis C Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomized, Open-label Study to Evaluate the Hepatitis C Virus (HCV) Burden in Patients Receiving Cyclosporine (Neoral or CSA) Versus Tacrolimus (Prograf) in de Novo Liver Recipients Receiving Mycophenolate Sodium (Myfortic): Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Biospecimen Retention:   Samples With DNA
Serum Tissue

Estimated Enrollment: 40
Study Start Date: May 2005
Detailed Description:
We will address the hypothesis that CSA has a superior antiviral effect against HCV than Tacrolimus by assessing serial HCV RNA levels in serum. We plan to address the hypothesis that CSA is more efficient in limiting viremia than Tacrolimus and that viremia is predictive of long-term clinical outcome of hepatic fibrosis that is known to impact on both graft and patient survival

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HCV positive patients undergoing orthotopic liver transplantation

Inclusion Criteria:

  • About to undergo a primary liver transplant (including living donor, split liver) and are HCV positive.
  • Willing and capable of giving written consent for study participation
  • Expected to be capable of study participation for full 24 months post-transplantation.
  • Allograft biopsies will be possible
  • Expected use of calcineurin inhibitor (Neoral or Tacrolimus) as primary immunosuppression An immunosuppressive regimen consisting of a calcineurin inhibitor (Neoral or Tacrolimus) in combination with Simulect and MYCOPHENOLATE SODIUM

Exclusion Criteria:

  • This is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
  • This is a liver transplant from a non-heart beating donor.
  • This is an ABO incompatible transplant.
  • Patients with serum creatinine level > 250 umol/L.
  • The recipient is seropositive for human immunodeficiency virus (HIV) antibodies.
  • Fulminant liver failure is the reason for transplant.
  • Patient is participating in other clinical trial involving exploratory drug
  • There is a known malignancy, or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma less than 5 cm meeting Milan criteria for transplantation5.
  • The patient is being transplanted for hepatic malignancy with greater than 5 known lesions.
  • Severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.
  • A female transplant candidate is pregnant, lactating or of childbearing potential and not practicing an acceptable method of contraception.
  • An unlicensed drug or therapy has been administered within one month prior to study entry or if such therapy is to be instituted post-transplantation.
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Please refer to this study by its identifier: NCT00710801

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Principal Investigator: Andrew L Mason, MD University of Alberta
  More Information

Responsible Party: University of Alberta Identifier: NCT00710801     History of Changes
Other Study ID Numbers: COLO400A2427 
Study First Received: July 2, 2008
Last Updated: September 14, 2011
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Alberta:
Hepatitis C Virus
Liver Transplant

Additional relevant MeSH terms:
Hepatitis C
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases processed this record on May 23, 2016