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A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation - NCT01074203-55905(Clinical Trial 563243)



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City:  Rochester
State:  
MN
Zip Code: 55905
Conditions: Hepatitis C Recurrence
Purpose: Recurrence of Hepatitis C virus infection (HCV) is universal after orthotopic liver transplantation (LTx) and is associated with allograft failure, death and need for re-transplantation. Currently, there are no effective therapies to prevent HCV recurrence. Nitazoxanide (NTZ), an oral thiazolide anti-infectious agent, was safe, well tolerated and effective in achieving sustained viral response in patients with chronic HCV genotype 4. Its role in the prevention of HCV recurrence after liver transplantation has not been studied. The investigators propose to conduct an open label pilot study examining the role of NTZ in the prevention of HCV re-infection in eight patients undergoing LTx. First time transplant recipients for chronic HCV without history of renal failure or HIV/HBV co-infection, will receive NTZ immediately prior to LTx and for 3 days thereafter. The primary endpoint is the number of patients who remain HCV-RNA-negative at day 7 after LTx. If at least one patient remains negative, the study will be determined to be positive. Additionally, the investigators will examine the viral kinetics of HCV, tolerability and safety of NTZ.
Study summary: Recurrence of Hepatitis C virus infection (HCV) is universal after orthotopic liver transplantation (LTx) and is associated with allograft failure, death and need for re-transplantation. Currently, there are no effective therapies to prevent HCV recurrence. Nitazoxanide (NTZ), an oral thiazolide anti-infectious agent, was safe, well tolerated and effective in achieving sustained viral response in patients with chronic HCV genotype 4. Its role in the prevention of HCV recurrence after liver transplantation has not been studied. We propose to conduct an open label pilot study examining the role of NTZ in the prevention of HCV re-infection in eight patients undergoing LTx. First time transplant recipients for chronic HCV without history of renal failure or HIV/HBV co-infection, will receive NTZ immediately prior to LTx and for 3 days thereafter. The primary endpoint is the number of patients who remain HCV-RNA-negative at day 7 after LTx. If at least one patient remains negative, the study will be determined to be positive. Additionally, we will examine the viral kinetics of HCV, tolerability and safety of NTZ.
Criteria: Inclusion Criteria: - Adult male or female patients age 18-75 - HCV infection identified by positive, quantifiable HCV RNA prior to transplant Exclusion Criteria: - Scheduled recipient of living donor transplantation - History of chronic hepatitis B or HIV infection - Transplantation for fulminant hepatic failure - Estimated glomerular filtration rate <60ml/min - Women who are pregnant or breast feeding and men or women that are sexually active but do not agree to use acceptable birth control
Study is available at: Mayo Clinic College of Medicine
Rochester, MN 55905
United States

Primary Contact:
Stacy Anderson, Rn
Email: anderson.stacy@mayo.edu
Phone: 507-538-9552

Secondary Contact:
Stacy Anderson, RN
Email: anderson.stacy@mayo.edu
Phone: 507-538-9552
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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