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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

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.

• 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.