NCT00637923

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Nitazoxanide	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.
DRUG	Placebo	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.
BIOLOGICAL	Peginterferon alfa-2a	One weekly injection of 180µg of peginterferon α-2a for 48 weeks.
DRUG	Ribavirin	Weight-based ribavirin for 48 weeks.

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-03-18
• Last updated: 2014-02-10
• Results posted: 2014-01-06

Locations

10 sites across 1 country: United States