Official Title: “Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Hepatitis C”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Drug: 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.
• Drug: 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.
• Biological: Peginterferon alfa-2a
  • One weekly injection of 180µg of peginterferon α-2a for 48 weeks.
• Drug: Ribavirin
  • Weight-based ribavirin for 48 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 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.
• Placebo Comparator: 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.

Primary Measures

• Sustained virologic response (HCV RNA below lower limit of detection)
  • Time Frame: 24 weeks after end of treatment
    Safety Issue?: No

Secondary Measures

• End of treatment response (HCV RNA below lower limit of detection)
  • Time Frame: At end of treatment
    Safety Issue?: No
• Early virologic response (HCV RNA below lower limit of detection)
  • Time Frame: After 12 weeks combination treatment
    Safety Issue?: No
• Rapid virologic response (HCV RNA below lower limit of detection)
  • Time Frame: After 4 weeks combination treatment
    Safety Issue?: No
• Changes in ALT
  • Time Frame: From baseline to weeks 8, 16, end of treatment and end of follow-up
    Safety Issue?: No

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-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab.
• Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score >6 or 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 ULN.
• Hypothyroidism or hyperthyroidism not effectively treated with medication.
• HgbA1c >7.5 or history of diabetes mellitus.
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Romark Laboratories L.C.

Overall Clinical Trial Officials and Contacts

Emmet B Keeffe, MD, MACP Study Director Romark Laboratories L.C.  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637923

Study ID Number: RM01-2026

ClinicalTrials.gov Identifier: NCT00637923

Health Authority: United States: Food and Drug Administration