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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Romark Laboratories L.C.
• Treatments: Interferon-alpha; Nitazoxanide; Peginterferon alfa-2a

Criteria

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.