NCT00421434

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

Randomized Study of Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin and Peginterferon-Ribavirin in the Treatment of Chronic Hepatitis C

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Nitazoxanide	One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
BIOLOGICAL	Peginterferon alfa-2a	Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
BIOLOGICAL	Peginterferon alfa-2a	Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
DRUG	Ribavirin	Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.
DRUG	Ribavirin	Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-01-12
• Last updated: 2008-09-25

Locations

2 sites across 1 country: Egypt