drugset / Trial / NCT00421434

Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

NCT00421434

Phase 2/3 Completed 121 enrolled Romark Laboratories L.C.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C genotype 4. The study will also evaluate the effect of the studied treatment regimens on end of treatment virologic response, ALT normalization and safety parameters.

Timeline

Start
2006-06
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitazoxanide Other / unclassified 500 mg Oral
Comparator Ribavirin Small molecule 1000 mg Oral
Comparator Ribavirin Small molecule 1200 mg Oral
Comparator Peginterferon alfa-2a Protein / enzyme biologic 180 ug Other