Eligibility

Please note:

Your doctor can help you interpret these criteria and help determine whether you are an appropriate candidate for enrollment in this trial. In addition, you may speak with a STEALTH C-3 physician / Study Coordinator for more information.

You may also call the Romark Information Center at (877) 925-4642 between the hours of 8.30 AM and 5.30 PM EST for information. Calling a STEALTH C-3 trial center or Romark Laboratories does not place you under any obligation to participate in the STEALTH C-3 clinical trial.

STEALTH C-3 Inclusion Criteria

• Age ≥18 years.
• Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay (EIA) for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA.
• Chronic liver disease consistent with chronic hepatitis C as documented by liver biopsy within 36 months prior to enrollment.
• HCV genotype 1.

STEALTH C-3 Exclusion Criteria

• Patients that have previously received treatment with any interferon (including peginterferon, albuferon, etc.) or any interferon-based treatment regimen for chronic hepatitis C.
• Patients unable to take oral medications.
• Use of herbal preparations (e.g., milk thistle, licorice, etc.) within 30 days prior to enrollment.
• Females of child-bearing age who are pregnant, breast-feeding or not using birth control and are sexually active. Female patients of child-bearing potential that are sexually active must have a baseline pregnancy test and must agree to continue two acceptable methods of birth control for the duration of the study and for 6 months post-treatment. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study.
• Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active. Male patients with female partners of child-bearing potential may be enrolled if they are advised of the teratogenic/embryocidal risks associated with ribavirin and if they agree to practice effective contraception using two effective forms of birth control during ribavirin therapy and for 6 months thereafter. Male patients must use a condom with spermicide as one of the two forms.
• Any investigational drug therapy within 30 days prior to enrollment.
• Patients with other causes of liver disease including autoimmune hepatitis.
• Transplant recipients receiving immune suppression therapy.
• Patients with screening tests positive for anti-HAV IgM, HBsAg, anti-HBc IgM or anti-HIV Ab.
• Patients with decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP (Child-Turcotte-Pugh) score >6 or MELD (Model for End-stage Liver Disease) score >8.
• Patients with an alcohol consumption of >40 g per day, or if in the opinion of the investigator, an alcohol use pattern that will interfere with the study.
• Patients with absolute neutrophil count (ANC) <1500 cells/mm3; platelet count <135,000 cells/mm3; hemoglobin <12 g/dL for women and <13 g/dL for men; or serum creatinine concentration ≥1.5 times upper limit of normal (ULN).
• Patients with either hypothyroidism or hyperthyroidism not effectively treated with medication. [Any patient with previously undiagnosed thyroid disease picked up at screening must be medically evaluated and excluded until a diagnosis is made and is stable on appropriate therapy for at least six months.].
• Patients with HgbA1c > 7.5 or with a history of diabetes mellitus.
• Patients with body mass index (BMI) >34.
• Patients with a history or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, hypertensive and not on a stable effective treatment regimen, significant arrhythmia).
• Patients with a history or other clinical evidence of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment.
• Patients with serious or severe bacterial infection(s).
• Patients with ulcerative or hemorrhagic/ischemic colitis.
• Patients with pancreatitis.
• Patients with a history of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization.
• Patients with a history of uncontrolled severe seizure disorder.
• Patients requiring concomitant theophylline or methadone.
• Patients with a history of immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) requiring more than intermittent nonsteroidal anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids.
• Patients with history or other evidence of severe retinopathy (e.g., CMV retinitis, macular degeneration, etc.) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension.
• Patients with hemoglobinopathies (e.g., 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 nitazoxanide or any of the excipients comprising the nitazoxanide tablets, peginterferon -2a injectable solution or ribavirin tablets.