Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Nitazoxanide; Placebo; Peginterferon alfa-2a; Ribavirin
Intervention description: One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.; One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.; One weekly injection of 180µg of peginterferon α-2a for 48 weeks.; Weight-based ribavirin for 48 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Nitazoxanide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic

Summary:

      The purpose of this study is to determine if nitazoxanide in combination with peginterferon
      alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in
      treatment-naive patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C genotype 1.

        Exclusion Criteria:

          -  Patients that have previously received treatment with any interferon or
             interferon-based treatment for chronic hepatitis C.

          -  Females of child-bearing age who are either pregnant, breast-feeding or not using
             birth control and are sexually active.

          -  Males whose female partners are either pregnant or of child-bearing potential or not
             using birth control and are sexually active.

          -  Other causes of liver disease including autoimmune hepatitis.

          -  Transplant recipients receiving immune suppression therapy.

          -  Screening tests positive for Anti-Hepatitis A Virus Immunoglobulin M Antibody
             (anti-HAV IgM Ab), Hepatitis B's antigen (HBsAg), Anti-Hepatitis B core Immunoglobulin
             M Antibody (anti-HBc IgM Ab) or Anti-Human Immunodeficiency Virus Antibody (anti-HIV
             Ab).

          -  Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic
             encephalopathy, Child-Turcotte-Pugh (CTP) score >6 or Model for End-stage Liver
             Disease (MELD) score >8.

          -  Alcohol consumption of >40 grams per day or an alcohol use pattern that will interfere
             with the study.

          -  Absolute neutrophil count <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).

          -  Hypothyroidism or hyperthyroidism not effectively treated with medication.

          -  Hemoglobin A1C (HgbA1c) >7.5 or history of diabetes mellitus.

          -  Body Mass Index (BMI) >34.

          -  History or other clinical evidence of significant or unstable cardiac disease.

          -  History or other clinical evidence of chronic pulmonary disease associated with
             functional impairment.

          -  Serious or severe bacterial infection(s).

          -  Ulcerative or hemorrhagic/ischemic colitis.

          -  Pancreatitis.

          -  History of severe or uncontrolled psychiatric disease, including severe depression,
             history of suicidal ideation, suicidal attempts or psychosis requiring medication
             and/or hospitalization.

          -  History of uncontrolled severe seizure disorder.

          -  Requires concomitant theophylline or methadone.

          -  History of immunologically mediated disease requiring more than intermittent
             anti-inflammatory medications for management or that requires frequent or prolonged
             use of corticosteroids.

          -  History or other evidence of severe retinopathy or clinically relevant
             ophthalmological disorder due to diabetes mellitus or hypertension.

          -  Hemoglobinopathies.

          -  History of hypersensitivity or intolerance to nitazoxanide or any of the excipients
             comprising the nitazoxanide tablets, peginterferon alfa-2a injectable solution or
             ribavirin tablets.