4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C

Study of a 4-Week Lead-In With Nitazoxanide Followed By 36 Weeks of Nitazoxanide Plus Peginterferon Alfa-2a in the Treatment of Chronic Hepatitis C

The purpose of this study is to determine if taking nitazoxanide alone for 4 weeks followed by 36 weeks of nitazoxanide plus peginterferon is superior to peginterferon plus ribavirin (standard of care) for 48 weeks.

Inclusion Criteria:

• Chronic hepatitis C

Exclusion Criteria:

• Previously failed to respond to at least 12 weeks of peginterferon plus ribavirin combination therapy.
• Unable to take oral medication.
• Females who are either pregnant, breast-feeding or not using birth control.
• Males whose female partners are pregnant or plan to become pregnant.
• Other causes of liver disease (for example, autoimmune hepatitis, decompensated liver disease).
• Patients with HIV, HAV, HBV or HDV.
• Patients with a history of alcoholism or with an alcohol consumption of more than 40 grams per day.
• Patients with hemoglobinopathies (for example, thalassemia major, sickle-cell anemia).
• History of hypersensitivity or intolerance to nitazoxanide or peginterferon.