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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Romark Laboratories L.C.
• Treatments: Interferon-alpha; Nitazoxanide; Peginterferon alfa-2a; Ribavirin

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.