Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients

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 treatment-naive patients.

Conditions

• Chronic Hepatitis C

Interventions

DRUG

Nitazoxanide

One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.

DRUG

Placebo

One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.

BIOLOGICAL

Peginterferon alfa-2a

One weekly injection of 180µg of peginterferon α-2a for 48 weeks.

DRUG

Ribavirin

Weight-based ribavirin for 48 weeks.

Sponsors & Collaborators

• Romark Laboratories L.C.

  lead INDUSTRY

Principal Investigators

• Emmet B Keeffe, MD, MACP · Romark Laboratories L.C.

• Norman Gitlin, MD · Atlanta Gastroenterology Associates

• Joseph K Lim, MD · Yale University

• Ira Jacobson, MD · New York Presbyterial-Weill Medical College of Cornell University

• Mitchell L Shiffman, MD · McGuire Veteran's Administration Medical Center

• Ronald E Pruitt, MD · Nashville Medical Research Institute

• Arthur Berman, DO · Florida Center for Gastroenterology

• Bruce Bacon, MD · St. Louis University Medical Center

• Nezam Afdhal, MD · Beth Israel Deaconess Medical Center

• David Johnson, MD · Bay Pines VA Healthcare System

• Raymond Chung, MD · Massachusetts General Hospital

• Vinod Rustgi, MD · Metropolitan Research

• Aijaz Ahmed, MD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2010-04-30

Completion

2010-04-30

Countries

• United States

Study Locations