Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00418639

Enrollment

Registered

2007-01-05

Start date

2005-02-28

Completion date

Unknown

Last updated

2007-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C

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.

Interventions

DRUGNitazoxanide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Virologic response	—

Secondary

Measure	Time frame
Sustained virologic response	—
Quantitative serum HCV RNA	—
Changes in ALT	—

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026