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A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Phoenix, Arizona, United States
Long Beach, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Start Date
August 1, 2009
Primary Completion Date
January 1, 2012
Completion Date
January 1, 2012
Last Updated
November 2, 2016
229
ACTUAL participants
Copegus
DRUG
Pegasys
DRUG
Placebo
DRUG
Placebo
DRUG
RO5190591 (Danoprevir)
DRUG
RO5190591 (Danoprevir)
DRUG
RO5190591 (Danoprevir)
DRUG
RO5190591 (Danoprevir)
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