Status:
COMPLETED
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients
Lead Sponsor:
Romark Laboratories L.C.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Chronic hepatitis C genotype 1.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00637923
Start Date
March 1 2008
End Date
April 1 2010
Last Update
February 10 2014
Active Locations (10)
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1
Palo Alto VA Healthcare System
Palo Alto, California, United States, 94304
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
3
Bay Pines VA Healthcare System
Bay Pines, Florida, United States, 33744
4
Florida Center for Gastroenterology
Largo, Florida, United States, 33777