This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up. As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
1000 mg bid orally, up to 24 weeks
100 mg bid orally, up to 24 weeks
180 mcg sc weekly, 24 weeks
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
100 mg bid orally, up to 24 weeks
Unnamed facility
La Jolla, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Marietta, Georgia, United States
Unnamed facility
Honolulu, Hawaii, United States
Unnamed facility
Honolulu, Hawaii, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Lutherville, Maryland, United States
Unnamed facility
Detroit, Michigan, United States
...and 22 more locations
Sustained virological response, defined as undetectable HVC RNA measured by Roche COBAS TaqMan HCV test
Time frame: 24 weeks after end of treatment
Safety: Incidence of adverse events
Time frame: 1.5 years
Virological response (HCV RNA measured by Roche COBAS Taqman HCV test)
Time frame: up to 48 weeks
Impact of Copegus (ribavirin) on efficacy of the direct-acting antiviral combination regimen: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time frame: 1.5 years
Comparison of 12 and 24 weeks of treatment duration: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time frame: 1.5 years
Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin
Time frame: up to 24 weeks
Viral resistance: HCV RNA sequencing and phenotypic analyses
Time frame: up to 48 weeks
Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time frame: 1.5 years
Quality of life: SF-36 questionnaire, Fatigue Severity Scale
Time frame: up to 36 weeks
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