At a glance
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Randomized Study for the Assessment of Nitazoxanide in the Treatment of Chronic Hepatitis C Genotype 4
In Brief
A Phase 3 clinical trial evaluating Pegylated interferon alfa-2a, Nitazoxanide, and 1 other intervention for Chronic Hepatitis c. Completed, enrolled 100 participants across 1 site.
Detailed Summary
Chronic hepatitis C has become an endemic disease in Egypt with a rising prevalence (genotype 4), worldwide it also poses a significant health burden. To date standard of care treatment (pegylated interferon and ribavirin) give modest results with a sustained virological response (SVR) of about 50%. Several pharmaceutical and herbal agents have been used with an aim to improve current results. Recent reports have suggested an increased SVR with the addition of Nitazoxanide to standard of care. The results are preliminary and need to be confirmed. This is a randomized trial to assess the efficacy of nitazoxanide added to standard of care compared to standard of care alone.
Study Details
Timeline
Interventions
Pegylated interferon 160ug once weekly 48 weeks
Nitazoxanide 500mg twice daily 4 weeks lead-in followed by triple therapy 48 weeks
Ribavirin (\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks