Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients

Not Recruiting

Trial ID: NCT00637923


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.

Official Title

Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Hepatitis C

Stanford Investigator(s)


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

   - 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.


drug: Placebo

biological: Peginterferon alfa-2a

drug: Ribavirin

drug: nitazoxanide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shawna Thunen