This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
Unnamed facility
Littleton, Colorado, United States
Unnamed facility
Chicago, Illinois, United States
Sustained virological response 12 weeks after treatment (SVR-12)
Time frame: up to 60 weeks
Sustained virological response 4 weeks after treatment
Time frame: up to 52 weeks
Virologic response over time
Time frame: 60 weeks
Proportion of patients who develop treatment resistance
Time frame: 60 weeks
Safety (incidence of adverse events)
Time frame: 60 weeks
Pharmacokinetics: trough concentration of RO4995855
Time frame: Day 1 and Week 8
Pharmacokinetics: trough concentration of RO5012433
Time frame: Day 1 and Week 8
Pharmacokinetics: trough concentration of boceprevir
Time frame: Day 1 and Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
180 microgram subcutaneous once a week for 48 weeks
800 mg three times a day for 24 weeks
800 mg three times a day for 48 weeks
1000 mg twice daily for 24 weeks
mericitabine placebo
boceprevir placebo
800 mg three times a day for 44 weeks
Unnamed facility
Shreveport, Louisiana, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
San Antonio, Texas, United States
Unnamed facility
Chesapeake, Virginia, United States
Unnamed facility
Calgary, Alberta, Canada
Unnamed facility
Vancouver, British Columbia, Canada
Unnamed facility
London, Ontario, Canada
...and 14 more locations