CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
Nitazoxanide +3 moredrug
Likely dose
Nitazoxanide 500 mgfrom 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/NCT00637923
NCT00637923Phase 2Completed
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Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Hepatitis C

Romark Laboratories L.C.·interventional·Posted Mar 18, 2008·Updated Feb 10, 2014

In Brief

A Phase 2 clinical trial evaluating Nitazoxanide, Placebo, and 2 other interventions for Chronic Hepatitis C. Completed, enrolled 112 participants across 10 sites.

Detailed Summary

The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in treatment-naive patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 18, 2008
Enrollment StartMar 1, 2008
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.3 years ago

Interventions

Nitazoxanidedrug

One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.

Placebodrug

One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.

Peginterferon alfa-2abiological

One weekly injection of 180µg of peginterferon α-2a for 48 weeks.

Ribavirindrug

Weight-based ribavirin for 48 weeks.