NCT00495391

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (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 patients that have previously failed to respond to treatment with peginterferon and ribavirin.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Nitazoxanide	One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
DRUG	Placebo	One oral placebo tablet twice daily for 52 weeks.
BIOLOGICAL	Peginterferon alfa-2a	Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
DRUG	Ribavirin	1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-07-03
• Last updated: 2014-05-08
• Results posted: 2014-01-06

Locations

10 sites across 1 country: United States