NCT01276756

Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)

Randomized Study for the Assessment of Nitazoxanide in the Treatment of Chronic Hepatitis C Genotype 4

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis c

Interventions

Type	Name	Description
DRUG	Pegylated interferon alfa-2a	Pegylated interferon 160ug once weekly 48 weeks
DRUG	Nitazoxanide	Nitazoxanide 500mg twice daily 4 weeks lead-in followed by triple therapy 48 weeks
DRUG	Ribavirin	Ribavirin (\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-01-13
• Last updated: 2013-05-03
• Results posted: 2013-05-03

Locations

1 site across 1 country: Egypt