A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
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.
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.