Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C
Trial ID or NCT#
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.
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
- - 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).
- - 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.
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