Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Nitazoxanide plus peginterferon alfa-2b
• Drug: Peginterferon alfa-2b

Primary Measures

• Virologic response

Secondary Measures

• 2 log drop in serum HCV RNA
• Change in ALT

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Romark Laboratories L.C.

Overall Clinical Trial Officials and Contacts

Yehia El-Gohary, MD Principal Investigator Department of Tropical Medicine & Infectious Diseases, Alexandria University  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00418054

Study ID Number: RM01-2022

ClinicalTrials.gov Identifier: NCT00418054

Health Authority: Egypt: Ministry of Health and Population