Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
The main objective of antiviral therapy of patients with chronic hepatitis C (CHC) is the
sustained elimination of the hepatitis C virus (HCV). The standard of care (SOC) is
peginterferon alfa-2a/-2b with ribavirin for 48 weeks or 24 weeks according to HCV genotype.
However, this approach is not sufficient to substantially improve the sustained virologic
response (SVR) rates. Therefore, new therapies are needed to treat patients with hepatitis C
virus (HCV) infection. Nitazoxanide (NTZ), originally used to treat cryptosporidium parvum
infection, recently was shown to have an unexpected antiviral activity in the HCV replicon
system and in chronically infected patients.
The aim of this work is to study impact of nitazoxanide therapy in addition to
peginterferon/ribavirin combination on virologic responses in patients with chronic hepatitis
C genotype 4.
Patients will be enrolled in this study and will be randomly assigned in a 1:1 ratio into 2
groups:
Group A: comprises 100 CHC patients who will receive the standard of care treatment,
peginterferon-alf 2a plus weight-based ribavirin for 48 weeks.
Group B: comprises 100 CHC patients who will receive nitazoxanide monotherapy at a dose of
500 mg twice daily for 12 weeks as a lead-in phase followed by triple therapy, nitazoxanide
500 mg twice daily plus peginterferon alfa-2a, and weight-based ribavirin for 48 weeks.
Data will be collected and statistical analysis will be done comparing the groups regarding
response to antiviral therapy. Final results will be discussed and compared to similar
studies published in peer reviewed journals and international conferences.