Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

Not Recruiting

Trial ID: NCT00495391

Purpose

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 patients that have previously failed to respond to treatment with peginterferon and ribavirin.

Official Title

Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Patients With Hepatitis C Who Have Failed to Respond to a Prior Course of Peginterferon and Ribavirin

Stanford Investigator(s)

Eligibility

Inclusion Criteria:

* Chronic hepatitis C genotype 1.
* Failed to respond to ≥12 weeks of peginterferon and ribavirin (\<2 log10 drop in Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 12 or detectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 24).

Exclusion Criteria:

* 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 antigen 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) \>28.
* 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.

Intervention(s):

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
6507235512