CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Pegylated interferon alfa-2a +2 moredrug
Likely dose
Nitazoxanide 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01276756
NCT01276756Phase 3Completed

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

Cairo University·interventional·Posted Jan 13, 2011·Updated May 3, 2013

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2011
Enrollment StartDec 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.5 years ago

Interventions

Pegylated interferon alfa-2adrug

Pegylated interferon 160ug once weekly 48 weeks

Nitazoxanidedrug

Nitazoxanide 500mg twice daily 4 weeks lead-in followed by triple therapy 48 weeks

Ribavirindrug

Ribavirin (\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks