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Sponsored by: |
Romark Laboratories L.C. |
Information provided by: | Romark Laboratories L.C. |
ClinicalTrials.gov Identifier: | NCT00495391 |
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.
Condition | Intervention | Phase |
Chronic Hepatitis C |
Drug: Nitazoxanide Drug: Placebo Biological: Peginterferon alfa-2a Drug: Ribavirin |
Phase II |
MedlinePlus related topics: | Hepatitis Hepatitis C |
Drug Information available for: | Ribavirin Peginterferon Alfa-2a Nitazoxanide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 60 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
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.
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Drug: Nitazoxanide
One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Biological: Peginterferon alfa-2a
Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
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.
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2: Placebo Comparator
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.
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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.
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
Stanford University School of Medicine | |||||
Stanford, California, United States, 94305 | |||||
VA Palo Alto Healthcare System | |||||
Palo Alto, California, United States, 94304 | |||||
United States, Connecticut | |||||
Yale University Digestive Diseases | |||||
New Haven, Connecticut, United States, 06520 | |||||
United States, Florida | |||||
University of Florida Hepatology | |||||
Gainesville, Florida, United States, 32610 | |||||
Florida Center for Gastroenterology | |||||
Largo, Florida, United States, 33777 | |||||
United States, Georgia | |||||
Atlanta Gastroenterology Associates | |||||
Atlanta, Georgia, United States, 30308 | |||||
United States, New York | |||||
Weill Cornell Medical College | |||||
New York, New York, United States, 10021 | |||||
United States, Tennessee | |||||
Nashville Medical Research Institute | |||||
Nashville, Tennessee, United States, 37205 | |||||
United States, Texas | |||||
Brooke Army Medical Center | |||||
Fort Sam Houston, Texas, United States, 78234 | |||||
United States, Virginia | |||||
McGuire VA Medical Center | |||||
Richmond, Virginia, United States, 23249 |
Romark Laboratories L.C. |
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 Cornell Medical College |
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 |
Responsible Party: | Romark Laboratories, L.C. ( Anthony Shane Jackson, PharmD; Director, Medical Science ) |
Study ID Numbers: | RM01-2025 |
First Received: | July 2, 2007 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00495391 |
Health Authority: | United States: Food and Drug Administration |
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