Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT00637923
- Lead Sponsor
- Romark Laboratories L.C.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Chronic hepatitis C genotype 1.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Peginterferon alfa-2a One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. 1 Ribavirin One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. 2 Placebo One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. 2 Peginterferon alfa-2a One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. 1 Nitazoxanide One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. 2 Ribavirin One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
- Primary Outcome Measures
Name Time Method Sustained Virologic Response (HCV RNA Below Lower Limit of Detection) 24 weeks after end of treatment Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
- Secondary Outcome Measures
Name Time Method Changes in ALT From baseline to end of follow up This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
End of Treatment Response (HCV RNA Below Lower Limit of Detection) At end of treatment Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.
Early Virologic Response (HCV RNA Below Lower Limit of Detection) After 12 weeks combination treatment Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.
Rapid Virologic Response (HCV RNA Below Lower Limit of Detection) After 4 weeks combination treatment Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.
Trial Locations
- Locations (10)
Florida Center for Gastroenterology
🇺🇸Largo, Florida, United States
New York Presbyterian-Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Palo Alto VA Healthcare System
🇺🇸Palo Alto, California, United States
Bay Pines VA Healthcare System
🇺🇸Bay Pines, Florida, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States