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Sponsored by: |
Valeant Pharmaceuticals North America |
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Information provided by: | Valeant Pharmaceuticals North America |
ClinicalTrials.gov Identifier: | NCT00305383 |
The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.
Condition | Intervention | Phase |
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Hepatitis C, Chronic |
Drug: Viramidine Drug: Peginterferon alfa-2b |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naive Patients With Chronic Hepatitis C |
Estimated Enrollment: | 100 |
Study Start Date: | November 2005 |
Study Completion Date: | May 2007 |
This Phase 2b multicenter study, which is being conducted solely in the United States, consists of a randomized, double-blind, monotherapy period, where patients will receive either viramidine or placebo for 4 weeks. After the monotherapy period, all patients will receive viramidine plus peginterferon alfa-2b combination therapy for 48 weeks in an open-label fashion and will then participate in a 24-week follow-up period after completion of combination therapy. The RVR at CT Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy will be examined. The differences in virological response during treatment and end of follow-up between African-Americans and Caucasians (non-Hispanics), as well as a correlation between duration of viral negativity (DVN) and sustained virologic response (SVR) based on race and dosing regimen, will also be assessed.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Mateo Medical Center | |
San Mateo, California, United States, 94403 | |
University of Southern California -- Keck School of Medicine | |
Los Angeles, California, United States, 90033 | |
United States, Florida | |
Bach and Godofsky | |
Bradenton, Florida, United States, 34205 | |
University of Miami -- Center for Liver Diseases | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
Digestive Healthcare of Georgia | |
Atlanta, Georgia, United States, 30309 | |
United States, Maryland | |
Maryland Digestive Disease Research | |
Laurel, Maryland, United States, 20707 | |
United States, New Jersey | |
Atlantic Gastroenterology Associates | |
Egg Harbor Township, New Jersey, United States, 08234 | |
United States, New York | |
Liver Center of Long Island | |
Plainview, New York, United States, 11803 | |
United States, Pennsylvania | |
Thomas Jefferson University -- Gastroenterology and Hepatology | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Utah | |
Mountain West Gastroenterology -- Research Office | |
Salt Lake City, Utah, United States, 84121 | |
United States, Virginia | |
Metropolitan Research -- Georgetown Medical Center | |
Fairfax, Virginia, United States, 22031 |
Study ID Numbers: | RNA003142-202 |
Study First Received: | March 17, 2006 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00305383 |
Health Authority: | United States: Food and Drug Administration |
Viramidine Peginterferon alfa-2b Valeant |
Hepatitis C Rapid virologic response HCV RNA |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Hepatitis, Viral, Human Hepatitis Virus Diseases |
Digestive System Diseases Peginterferon alfa-2b Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
Anti-Infective Agents RNA Virus Infections Flaviviridae Infections Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions |