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Sponsors and Collaborators: |
University of Alberta Novartis |
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Information provided by: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT00710801 |
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.
Condition |
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Hepatitis C Virus |
Study Type: | Observational |
Study Design: | Cohort, 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 |
Serum Tissue
Estimated Enrollment: | 40 |
Study Start Date: | May 2005 |
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 |
HCV positive patients undergoing orthotopic liver transplantation
Inclusion Criteria:
Exclusion Criteria:
Contact: Brenda L Walker, BScN | 780-407-1765 | brenda.walker@capitalhealth.ca |
Canada, Alberta | |
University of Alberta Hospital | Recruiting |
Edmonton, Alberta, Canada, T6G 2B7 |
Principal Investigator: | Andrew L Mason, MD | University of Alberta |
Responsible Party: | University of Alberta ( Dr. Andrew L. Mason ) |
Study ID Numbers: | COLO400A2427 |
Study First Received: | July 2, 2008 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00710801 History of Changes |
Health Authority: | Canada: Ethics Review Committee; Canada: Health Canada |
Hepatitis C Virus HCV Liver Transplant |
Cyclosporine Tacrolimus Myfortic |
Virus Diseases Hepatitis Liver Diseases Cyclosporine Digestive System Diseases Mycophenolate mofetil |
Mycophenolic Acid Hepatitis, Viral, Human Tacrolimus Hepatitis C Cyclosporins Recurrence |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases |
Digestive System Diseases Flaviviridae Infections Hepatitis, Viral, Human Hepatitis C |