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Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

NCT00421434 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2008-09-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C genotype 4. The study will also evaluate the effect of the studied treatment regimens on end of treatment virologic response, ALT normalization and safety parameters.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Nitazoxanide

One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.

BIOLOGICAL

Peginterferon alfa-2a

Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.

BIOLOGICAL

Peginterferon alfa-2a

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

DRUG

Ribavirin

Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.

DRUG

Ribavirin

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

Sponsors & Collaborators

  • Romark Laboratories L.C.

    lead INDUSTRY

Principal Investigators

  • Yehia El-Gohary, MD · Department of Tropical Medicine & Infectious Diseases, Alexandria University

  • Asem Elfert, MD · Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Egypt

Study Locations

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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 NCT00421434 on ClinicalTrials.gov