Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

January 3, 2007 updated by: Romark Laboratories L.C.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Department of Tropical Medicine & Infectious Diseases, Alexandria University
      • Cairo, Egypt
        • Cairo Liver & GIT Center
      • Tanta, Egypt
        • Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Virologic response

Secondary Outcome Measures

Outcome Measure
Sustained virologic response
Quantitative serum HCV RNA
Changes in ALT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romark Laboratories L.C.

Investigators

  • Principal Investigator: Samir M Kabil, MD, Cairo Liver & GIT Center
  • Principal Investigator: Yehia El-Gohary, MD, Department of Tropical Medicine & Infectious Diseases, Alexandria University
  • Principal Investigator: Asem Elfert, MD, Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 5, 2007

Study Record Updates

Last Update Posted (Estimate)

January 5, 2007

Last Update Submitted That Met QC Criteria

January 3, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM01-3027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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