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Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)

NCT01276756 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-05-03

Study results available
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Summary

Chronic hepatitis C has become an endemic disease in Egypt with a rising prevalence (genotype 4), worldwide it also poses a significant health burden. To date standard of care treatment (pegylated interferon and ribavirin) give modest results with a sustained virological response (SVR) of about 50%. Several pharmaceutical and herbal agents have been used with an aim to improve current results. Recent reports have suggested an increased SVR with the addition of Nitazoxanide to standard of care. The results are preliminary and need to be confirmed. This is a randomized trial to assess the efficacy of nitazoxanide added to standard of care compared to standard of care alone.

Conditions

  • Chronic Hepatitis c

Interventions

DRUG

Pegylated interferon alfa-2a

Pegylated interferon 160ug once weekly 48 weeks

DRUG

Nitazoxanide

Nitazoxanide 500mg twice daily 4 weeks lead-in followed by triple therapy 48 weeks

DRUG

Ribavirin

Ribavirin (\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks

Sponsors & Collaborators

  • Egyptian Railway Hospital

    collaborator OTHER

  • Cairo University

    lead OTHER

Principal Investigators

  • Hany M Shehab, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-11-30
Completion
2012-11-30

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 NCT01276756 on ClinicalTrials.gov