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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
One oral placebo tablet twice daily for 52 weeks.
Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
VA Palo Alto Healthcare System
Palo Alto, California, United States
Stanford University School of Medicine
Stanford, California, United States
Yale University Digestive Diseases
New Haven, Connecticut, United States
Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
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.
Time frame: 24 weeks after end of treatment
End of Treatment Response (HCV RNA Below Lower Limit of Detection)
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.
Time frame: At end of treatment
Early Virologic Response (HCV RNA Below Lower Limit of Detection)
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.
Time frame: After 12 weeks combination treatment
Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.
Time frame: After 4 weeks combination treatment
Changes in ALT
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.
Time frame: From baseline to week 8
Changes in ALT
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.
Time frame: From baseline to week 16
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1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
University of Florida Hepatology
Gainesville, Florida, United States
Florida Center for Gastroenterology
Largo, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Weill Cornell Medical College
New York, New York, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Changes in ALT
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.
Time frame: From baseline to end of treatment
Changes in ALT
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.
Time frame: From baseline to end of follow up