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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
This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Birmingham, Alabama, United States
Tucson, Arizona, United States
Anaheim, California, United States
Fresno, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Merced, California, United States
Palo Alto, California, United States
Pasadena, California, United States
Start Date
January 1, 2008
Primary Completion Date
December 1, 2010
Completion Date
December 1, 2010
Last Updated
May 7, 2012
155
ACTUAL participants
peginterferon alfa-2a [Pegasys]
DRUG
ribavirin [Copegus]
DRUG
Pioglitazone
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT05870969
NCT03987503
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04382404