Official Title: “Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in the Treatment of Chronic Hepatitis C”

This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on end of treatment virologic response, sustained virologic response, reduction of quantitative serum HCV RNA, changes in ALT and safety parameters.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Nitazoxanide

Primary Measures

• Virologic response

Secondary Measures

• Sustained virologic response
• Quantitative serum HCV RNA
• Changes 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.

Exclusion Criteria:

• Patients unable to take oral medications.
• Use of interferon alpha within 90 days or ribavirin within 30 days prior to enrollment.
• Females of child bearing age 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.
• Patients with other causes of liver disease.
• Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus based on enzyme immunoassay.
• Patients with history of alcoholism or with an alcohol consumption of >40 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 nitazoxanide or any of the excipients comprising the nitazoxanide tablets.

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

Samir M Kabil, MD Principal Investigator Cairo Liver & GIT Center  

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00418639

Study ID Number: RM01-3027

ClinicalTrials.gov Identifier: NCT00418639

Health Authority: Egypt: Ministry of Health and Population