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A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4
This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is \<200.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
La Jolla, California, United States
Bradenton, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Kansas City, Missouri, United States
Lebanon, New Hampshire, United States
Start Date
February 1, 2010
Primary Completion Date
April 1, 2012
Completion Date
April 1, 2012
Last Updated
November 2, 2016
168
ACTUAL participants
RO5024048
DRUG
Ribavirin [Copegus]
DRUG
peginterferon alfa-2a [Pegasys]
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