Hepatitis C, Chronic
Conditions
Brief summary
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.
Interventions
DRUGCopegus
1000 or 1200mg po daily for 24 or 48 weeks
DRUGPegasys
180micrograms sc weekly for 24 or 48 weeks
DRUGPlacebo
po for 12 weeks
DRUGRO5190591 (Danoprevir)
300mg po q8h for 12 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * chronic hepatitis C, genotype 1; * treatment-naive.
Exclusion criteria
* liver cirrhosis and other forms of liver disease; * HIV infection; * hepatocellular cancer; * cardiac disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virological response | 24 weeks after end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Virological response over time | At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment |
| Adverse events; laboratory parameters | Throughout study, laboratory parameters every 2 to 6 weeks |
Countries
Australia, Austria, Canada, France, Germany, Italy, United States
Outcome results
None listed