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Clinical Trials/NCT00418639
NCT00418639CompletedPhase 2

Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

Romark Laboratories L.C.3 sites in 1 country50 target enrollmentStarted: February 1, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
50
Locations
3
Primary Endpoint
Virologic response
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on end of treatment virologic response, sustained virologic response, reduction of quantitative serum HCV RNA, changes in ALT and safety parameters.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • •Patients unable to take oral medications.
  • •Use of interferon alpha within 90 days or ribavirin within 30 days prior to enrollment.
  • •Females of child bearing age 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.
  • •Patients with other causes of liver disease.
  • •Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus based on enzyme immunoassay.
  • •Patients with history of alcoholism or with an alcohol consumption of >40 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 nitazoxanide or any of the excipients comprising the nitazoxanide tablets.

Outcomes

Primary Outcomes

Virologic response

Secondary Outcomes

  • Sustained virologic response
  • Quantitative serum HCV RNA
  • Changes in ALT

Investigators

Sponsor Class
Industry

Study Sites (3)

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