Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00421434
Eligibility Criteria:
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.
* HCV genotype 4.
Exclusion Criteria:
* Patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy.
* Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
* Males whose female partners are pregnant.
* Patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease).
* Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus.
* Patients with a history of alcoholism or with an alcohol consumption of \>40 grams per day.
* Patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia).
* 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 any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectionable solution or ribavirin tablets.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00421434
Study Brief:
Protocol Section:
NCT00421434