Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C

Phase II, Multi-Center, Randomized, Double-Blind Study of Nitazoxanide Tablets Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Chronic Hepatitis C

The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis C.

Inclusion Criteria:

• Age ≥18 years.
• Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA.
• Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.
• HCV genotype 4.
• Patients that have not previously received peginterferon.

Exclusion Criteria:

• Patients unable to take oral medications.
• Use of ribavirin within 30 days prior to enrollment.
• Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
• Any investigational drug therapy within 30 days prior to enrollment other than through Romark study number RM01-3027.
• Patients with other causes of liver disease.
• Transplant recipients receiving immune suppression therapy.
• Patient co-infected with human immunodeficiency virus, hepatitis A virus, hepatitis B virus, or hepatitis D virus based on enzyme immunoassay.
• Patients with decompensated cirrhosis, thrombocytopenia (platelet count <80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or CTP scores >6.
• Patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of >20 grams per day.
• Patients who are clinically unstable.
• Patients with any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed.
• History of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets or peginterferon alfa-2b solution for injection.