Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of 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 evaluate the safety and efficacy of nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C genotype 4. The study will also evaluate the effect of the studied treatment regimens on end of treatment virologic response, ALT normalization and safety parameters.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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.