Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients
NCT ID: NCT00637923
Last Updated: 2014-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2008-03-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
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.
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.
Peginterferon alfa-2a
One weekly injection of 180µg of peginterferon α-2a for 48 weeks.
Ribavirin
Weight-based ribavirin for 48 weeks.
2
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.
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.
Peginterferon alfa-2a
One weekly injection of 180µg of peginterferon α-2a for 48 weeks.
Ribavirin
Weight-based ribavirin for 48 weeks.
Interventions
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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.
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.
Peginterferon alfa-2a
One weekly injection of 180µg of peginterferon α-2a for 48 weeks.
Ribavirin
Weight-based ribavirin for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Romark Laboratories L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Emmet B Keeffe, MD, MACP
Role: STUDY_DIRECTOR
Romark Laboratories L.C.
Norman Gitlin, MD
Role: PRINCIPAL_INVESTIGATOR
Atlanta Gastroenterology Associates
Joseph K Lim, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Ira Jacobson, MD
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterial-Weill Medical College of Cornell University
Mitchell L Shiffman, MD
Role: PRINCIPAL_INVESTIGATOR
McGuire Veteran's Administration Medical Center
Ronald E Pruitt, MD
Role: PRINCIPAL_INVESTIGATOR
Nashville Medical Research Institute
Arthur Berman, DO
Role: PRINCIPAL_INVESTIGATOR
Florida Center for Gastroenterology
Bruce Bacon, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis University Medical Center
Nezam Afdhal, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
David Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Bay Pines VA Healthcare System
Raymond Chung, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Vinod Rustgi, MD
Role: PRINCIPAL_INVESTIGATOR
Metropolitan Research
Aijaz Ahmed, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Palo Alto VA Healthcare System
Palo Alto, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
Florida Center for Gastroenterology
Largo, Florida, 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
New York Presbyterian-Weill Medical College of Cornell University
New York, New York, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Metropolitan Research
Fairfax, Virginia, United States
Countries
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Other Identifiers
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RM01-2026
Identifier Type: -
Identifier Source: org_study_id
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