A Randomized, Open-label Study of the Effect of PEGASYS ® Plus COPEGUS® With or Without Concomitant Pioglitazone (Actos®) on Early Viral Kinetics in Treatment-naive Patients With Chronic Hepatitis C, Genotype-1, and Insulin Resistance
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy
Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.
Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment
No
Clinical Trials
Study Director
Hoffmann-La Roche
United States: Food and Drug Administration
ML21301
NCT00545233
January 2008
December 2010
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Bettendorf, Iowa 52722 | |
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Birmingham, Alabama 35294 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Louisville, Kentucky 40207 | |
McLean, Virginia 22101 | |
Scarborough, Maine 04074 | |
Hackensack, New Jersey 07601 | |
Metairie, Louisiana 70006 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Eugene, Oregon | |
Indianapolis, Indiana | |
Charleston, South Carolina | |
Lebanon, New Hampshire | |
Tulsa, Oklahoma | |
Jackson, Mississippi | |
Salt Lake City, Utah 84112 |