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Status:

COMPLETED

Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

Lead Sponsor:

Romark Laboratories L.C.

Conditions:

Chronic Hepatitis C

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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, c...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2005

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00418639

Start Date

February 1 2005

Last Update

January 5 2007

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Department of Tropical Medicine & Infectious Diseases, Alexandria University

Alexandria, Egypt

2

Cairo Liver & GIT Center

Cairo, Egypt

3

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

Tanta, Egypt