Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT00710801
First received: July 2, 2008
Last updated: September 14, 2011
Last verified: September 2011

July 2, 2008
September 14, 2011
May 2005
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Complete list of historical versions of study NCT00710801 on ClinicalTrials.gov Archive Site
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Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation
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

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Serum Tissue

Non-Probability Sample

HCV positive patients undergoing orthotopic liver transplantation

Hepatitis C Virus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00710801
COLO400A2427
Not Provided
University of Alberta
University of Alberta
Novartis
Principal Investigator: Andrew L Mason, MD University of Alberta
University of Alberta
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP