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Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

NCT00495391 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-05-08

Study results available
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Summary

The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in patients that have previously failed to respond to treatment with peginterferon and ribavirin.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Nitazoxanide

One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

DRUG

Placebo

One oral placebo tablet twice daily for 52 weeks.

BIOLOGICAL

Peginterferon alfa-2a

Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

DRUG

Ribavirin

1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Sponsors & Collaborators

  • Romark Laboratories L.C.

    lead INDUSTRY

Principal Investigators

  • David Nelson, MD · University of Florida Hepatology

  • Stephen Harrison, MD · Brooke Army Medical Center

  • Arthur Berman, DO · Florida Center for Gastroenterology

  • Ronald Pruitt, MD · Nashville Medical Research Institute

  • Ahmed Aijaz, MD · Stanford University

  • Ramsey Cheung, MD · VA Palo Alto Health Care System

  • Ira Jacobson, MD · Weill Medical College of Cornell University

  • Mitchell Shiffman, MD · McGuire VA Medical Center

  • Joseph Lim, MD · Yale University Digestive Diseases

  • Norman Gitlin, MD · Atlanta Gastroenterology Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00495391 on ClinicalTrials.gov