Hepatitis C, Chronic
Conditions
Brief summary
This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.
Interventions
DRUGCopegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
DRUGDanoprevir
Danoprevir 50 mg BID
DRUGPegasys
Pegasys 180 microgram sc qw
DRUGRitonavir
Ritonavir 100 mg
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults patients, \>/=18 years of age * Chronic Hepatitis C, Genotype 1 and 4 * HCV RNA \>/=50,000 IU/mL * treatment-naive
Exclusion criteria
* Patients with cirrhosis or incomplete/transition to cirrhosis * Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test) | 24 weeks after end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of relapse rate | up to 24 weeks after end of treatment |
| Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses) | from baseline up to 72 weeks |
| Safety: Incidence of adverse events | from baseline up to 72 weeks |
| Evaluation of virological breakthrough (viral load rebound) rate | up to 72 weeks |
| Evaluation of pharmacokinetics (serum concentrations assessed by validated methods) | up to 72 weeks |
| Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test) | From baseline up to 72 weeks |
Countries
Austria, Brazil, Canada, France, Germany, Italy, Mexico, Puerto Rico, Spain, United Kingdom, United States
Outcome results
None listed