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

Launched by ROMARK LABORATORIES L.C. · Jan 10, 2007

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Eligibility criteria

• 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.
• Exclusion Criteria:
• • Patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy.
• • Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
• • Males whose female partners are pregnant.
• • Patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease).
• • Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus.
• • Patients with a history of alcoholism or with an alcohol consumption of \>40 grams per day.
• • Patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia).
• • 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, peginterferon alfa-2a injectionable solution or ribavirin tablets.