Hepatitis C, Chronic
Conditions
Brief summary
This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.
Interventions
DRUGdanoprevir + ritonavir
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
DRUGpeginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 12 weeks
1000-1200 mg orally daily in divided doses, 12 weeks
Sponsors
Hoffmann-La Roche
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients of East Asian or Southeast Asian origin, \>/= 18 years of age * Presence of chronic genotype 1 hepatitis C infection * Treatment-naïve
Exclusion criteria
* History or presence of decompensated liver disease * Presence or history of non-hepatitis C chronic liver disease * Positive for hepatitis B or HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | approximately 1.5 years |
| Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir | up to 14 days |
| Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System | from baseline to Week 36/48 |
| Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study | approximately 1.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration | approximately 1.5 years |
| Incidence of viral resistance to danoprevir | approximately 1.5 years |
| SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12 | approximately 1.5 years |
| Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4 | approximately 1.5 years |
| Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12 | approximately 1.5 years |
| Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration | approximately 1.5 years |
Countries
South Korea, Taiwan, Thailand
Outcome results
None listed