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