Status:
COMPLETED
Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Novartis
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
18-75 years
Brief Summary
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 ...
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 effi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00710801
Start Date
May 1 2005
Last Update
September 15 2011
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7