Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C (STEALTHC-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00495391
First received: July 2, 2007
Last updated: April 8, 2014
Last verified: April 2014

July 2, 2007
April 8, 2014
July 2007
February 2010   (final data collection date for primary outcome measure)
Sustained Virologic Response (HCV RNA Below Lower Limit of Detection) [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
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.
Sustained virologic response (HCV RNA below lower limit of detection) [ Time Frame: 24 weeks after end of treatment ]
Complete list of historical versions of study NCT00495391 on ClinicalTrials.gov Archive Site
  • End of Treatment Response (HCV RNA Below Lower Limit of Detection) [ Time Frame: At end of treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: After 12 weeks combination treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: After 4 weeks combination treatment ] [ Designated as safety issue: No ]
    Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.
  • Changes in ALT [ Time Frame: From baseline to week 8 ] [ Designated as safety issue: No ]
    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.
  • Changes in ALT [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]
    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.
  • Changes in ALT [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
    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.
  • Changes in ALT [ Time Frame: From baseline to end of follow up ] [ Designated as safety issue: No ]
    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) [ Time Frame: At end of treatment ]
  • Early virologic response (HCV RNA below lower limit of detection) [ Time Frame: After 12 weeks combination treatment ]
  • Rapid virologic response (HCV RNA below lower limit of detection) [ Time Frame: After 4 weeks combination treatment ]
  • Changes in ALT [ Time Frame: From baseline to weeks 8, 16, end of treatment and end of follow-up ]
Not Provided
Not Provided
 
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C
Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Patients With Hepatitis C Who Have Failed to Respond to a Prior Course of Peginterferon and Ribavirin

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 patients that have previously failed to respond to treatment with peginterferon and ribavirin.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Nitazoxanide
    One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
    Other Name: Alinia
  • Drug: Placebo
    One oral placebo tablet twice daily for 52 weeks.
  • Biological: Peginterferon alfa-2a
    Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
    Other Name: PEGASYS
  • Drug: Ribavirin
    1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
    Other Name: COPEGUS
  • Active Comparator: 1
    Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
    Interventions:
    • Drug: Nitazoxanide
    • Biological: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Placebo Comparator: 2
    Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
    Interventions:
    • Drug: Placebo
    • Biological: Peginterferon alfa-2a
    • Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic hepatitis C genotype 1.
  • Failed to respond to ≥12 weeks of peginterferon and ribavirin (<2 log10 drop in Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 12 or detectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 24).

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 antigen 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) >28.
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00495391
RM01-2025
Yes
Romark Laboratories L.C.
Romark Laboratories L.C.
Not Provided
Principal Investigator: David Nelson, MD University of Florida Hepatology
Principal Investigator: Stephen Harrison, MD Brooke Army Medical Center
Principal Investigator: Arthur Berman, DO Florida Center for Gastroenterology
Principal Investigator: Ronald Pruitt, MD Nashville Medical Research Institute
Principal Investigator: Ahmed Aijaz, MD Stanford University
Principal Investigator: Ramsey Cheung, MD VA Palo Alto Healthcare System
Principal Investigator: Ira Jacobson, MD Weill Medical College of Cornell University
Principal Investigator: Mitchell Shiffman, MD McGuire VA Medical Center
Principal Investigator: Joseph Lim, MD Yale University Digestive Diseases
Principal Investigator: Norman Gitlin, MD Atlanta Gastroenterology Associates
Romark Laboratories L.C.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP