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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT00495391

Run by

Romark Laboratories L.C.

People needed

64

Starts

2007-07-01

Expected to finish

2010-02-01

Last updated by the study team

2014-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• VA Palo Alto Healthcare System — Palo Alto, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• Yale University Digestive Diseases — New Haven, Connecticut, United States
• University of Florida Hepatology — Gainesville, Florida, United States
• Florida Center for Gastroenterology — Largo, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Weill Cornell Medical College — New York, New York, United States
• Nashville Medical Research Institute — Nashville, Tennessee, United States
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States
• McGuire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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