CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 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/NCT00495391
NCT00495391Phase 2Completed
CompareCT.gov

Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Patients With Hepatitis C Who Have Failed to Respond to a Prior Course of Peginterferon and Ribavirin

Romark Laboratories L.C.·interventional·Posted Jul 3, 2007·Updated May 8, 2014

In Brief

A Phase 2 clinical trial evaluating Nitazoxanide, Placebo, and 2 other interventions for Chronic Hepatitis C. Completed, enrolled 64 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 patients that have previously failed to respond to treatment with peginterferon and ribavirin.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 3, 2007
Enrollment StartJul 1, 2007
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.0 years ago

Interventions

Nitazoxanidedrug

One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Placebodrug

One oral placebo tablet twice daily for 52 weeks.

Peginterferon alfa-2abiological

Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Ribavirindrug

1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.