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

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

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
      • 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.
  • 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.

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
2 log drop in serum HCV RNA
Change 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: 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

December 1, 2005

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 4, 2007

Last Update Submitted That Met QC Criteria

January 3, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM01-2022

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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